HIgH-Flo Needle SetRecalls & reported problems across all models

We found 11 models of HIgH-Flo Needle Set by Repro Med Systems, Inc. in the FDA's device registry (GUDID). Together they are named in 14 adverse event reports in the FDA's MAUDE database, received between Apr 21, 2022 and Jul 6, 2026 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Contamination” (5 reports).

1 FDA recall record name at least one of these models by its device identifier.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

HIgH-Flo Needle Set recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Aug 20, 2019Terminated

   Mislabeled needle lengths

   Z-0051-2020 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported HIgH-Flo Needle Set problems

HIgH-Flo Needle Set models

11 models, most reported first. Each model has its own page with its reports, recalls and device details.

• HIgH-Flo™ Needle Set RMS22606

  Set, administration, intravascular
  1 recall0 reports
• HIgH-Flo™ Needle Set RMS22609

  Set, administration, intravascular
  2 reports
• HIgH-Flo™ Needle Set RMS52609

  Set, administration, intravascular
  2 reports
• HIgH-Flo™ Needle Set RMS12414

  Set, administration, intravascular
  2 reports
• HIgH-Flo™ Needle Set RMS32409

  Set, administration, intravascular
  2 reports
• HIgH-Flo™ Needle Set RMS32614

  Set, administration, intravascular
  1 report
• HIgH-Flo™ Needle Set RMS12409

  Set, administration, intravascular
  1 report
• HIgH-Flo™ Needle Set RMS22409

  Set, administration, intravascular
  1 report
• HIgH-Flo™ Needle Set RMS22414

  Set, administration, intravascular
  1 report
• HIgH-Flo™ Needle Set RMS32414

  Set, administration, intravascular
  1 report
• HIgH-Flo™ Needle Set RMS42412

  Set, administration, intravascular
  1 report

Recent HIgH-Flo Needle Set adverse event reports

The 14 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionJul 6, 2026Contamination

  KORU MEDICAL BECAME AWARE OF A REPORT FROM A CUSTOMER ON 09-JUN-2026 STATING "ONE (1) UNIT OF RMS12409 (LOT N.25J38N) HAS BEEN OBSERVED WITH VISUAL DEFECT/POSSIBLE CONTAMINANT ON THE TUBING." ON 09-JUN-2026, KORU QUALITY CONTROL PULLED ALL REMAINING INVENTORY ON THIS LOT (14 POUCHES) WHICH WERE VISUALLY INSPECTED, AND DEBRIS WAS FOUND IN 3 OF THE POUCHES. THE CUSTOMER PROVIDED PHOTOS OF THE POUCH CONFIRMING THE COMPLAINT. THERE WAS NO PATIENT INVOLVEMENT. A RETURN MATERIAL AUTHORIZATION WAS CREATED TO RETURN THE AFFECTED POUCH TO KORU MEDICAL. A REVIEW OF THE DEVICE HISTORY RECORD FOR HIGH-FLO NEEDLE SET RMS12409/LOT N.25J38N WAS PERFORMED AND NO NONCONFORMANCES OR ABERRANT CONDITIONS WERE NOTED. HIGH-FLO NEEDLE SETS ARE MANUFACTURED AND SEALED INTO THEIR PRIMARY STERILE BARRIER PACKAGING IN A CONTROLLED ENVIRONMENT. IN ADDITION, HIGH-FLO NEEDLE SETS ARE STERILIZED USING GAMMA IRRADIATION WHICH IS A HIGHLY PENETRATING AND EFFECTIVE STERILIZATION MODALITY. FURTHERMORE, VALIDATION OF THE STERILIZATION METHOD WAS PERFORMED USING A CONSERVATIVE METHOD (VDMAX25) WHICH PROVIDES A SAFETY MARGIN OVER ALTERNATE ACCEPTABLE VALIDATION METHODS. THE INSTRUCTIONS FOR USE FOR THE HIGH-FLO NEEDLE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25717674 ↗
• MalfunctionApr 20, 2026Contamination

  (B)(6) BECAME AWARE THAT, DURING INITIAL INCOMING INSPECTION AT A CUSTOMER WAREHOUSE IN JAPAN, UNIDENTIFIED BLACK DEBRIS OR CONTAMINATION WAS FOUND INSIDE EIGHT SEALED HIGH-FLO NEEDLE SET POUCHES AND ONE SEALED PRECISION FLOW RATE TUBING POUCH. ADDITIONALLY, TWO POUCHES FROM HIGH-FLO NEEDLE SET RMS12414/LOT N.86873 WERE FOUND TO BE DAMAGED, POTENTIALLY COMPROMISING THE STERILE BARRIER. MEDICAL DEVICE REPORTS (MDRS) ARE BEING FILED FOR EACH AFFECTED DEVICE MALFUNCTION AND LOT. MDR 1318360-2026-00009 IS BEING FILED DUE TO CONTAMINATION OF FOUR POUCHES ASSOCIATED WITH HIGH-FLO NEEDLE SET RMS22409/LOT N.25D32N. MDR 1318360-2026-00010 IS BEING FILED DUE TO CONTAMINATION OF ONE POUCH ASSOCIATED WITH HIGH-FLO NEEDLE SET RMS12414/LOT N.86873. MDR 1318360-2026-00011 IS BEING FILED DUE TO DELIVERY OF (POTENTIALLY) UNSTERILE PRODUCTS OF TWO POUCHES ASSOCIATED WITH HIGH-FLO NEEDLE SET RMS12414/LOT N.86873. MDR . IS BEING FILED DUE TO CONTAMINATION OF ONE POUCH ASSOCIATED WITH HIGH-FLO NEEDLE SET RMS22414/LOT N.86872. MDR 1318360-2026-00013 IS BEING FILED DUE TO CONTAMINATION OF ONE POUCH ASSOCIATED WITH PRECISION FLOW RATE TUBING FEXT/LOT T.87065. MDR 1318360-2026-00014 IS BEING FILED DUE TO C

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24932058 ↗
• MalfunctionApr 20, 2026Contamination

  KORU MEDICAL BECAME AWARE THAT, DURING INITIAL INCOMING INSPECTION AT A CUSTOMER WAREHOUSE IN JAPAN, UNIDENTIFIED BLACK DEBRIS OR CONTAMINATION WAS FOUND INSIDE EIGHT SEALED HIGH-FLO NEEDLE SET POUCHES AND ONE SEALED PRECISION FLOW RATE TUBING POUCH. ADDITIONALLY, TWO POUCHES FROM HIGH-FLO NEEDLE SET RMS12414/LOT N.86873 WERE FOUND TO BE DAMAGED, POTENTIALLY COMPROMISING THE STERILE BARRIER. MEDICAL DEVICE REPORTS (MDRS) ARE BEING FILED FOR EACH AFFECTED DEVICE MALFUNCTION AND LOT. MDR 1318360-2026-00009 IS BEING FILED DUE TO CONTAMINATION OF FOUR POUCHES ASSOCIATED WITH HIGH-FLO NEEDLE SET RMS22409/LOT N.25D32N. MDR 1318360-2026-00010 IS BEING FILED DUE TO CONTAMINATION OF ONE POUCH ASSOCIATED WITH HIGH-FLO NEEDLE SET RMS12414/LOT N.86873. MDR 1318360-2026-00011 IS BEING FILED DUE TO DELIVERY OF (POTENTIALLY) UNSTERILE PRODUCTS OF TWO POUCHES ASSOCIATED WITH HIGH-FLO NEEDLE SET RMS12414/LOT N.86873. MDR 1318360-2026-00012 IS BEING FILED DUE TO CONTAMINATION OF ONE POUCH ASSOCIATED WITH HIGH-FLO NEEDLE SET RMS22414/LOT N.86872. MDR 1318360-2026-00013 IS BEING FILED DUE TO CONTAMINATION OF ONE POUCH ASSOCIATED WITH PRECISION FLOW RATE TUBING FEXT/LOT T.87065. MDR 1318360-2026-00014

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24932045 ↗
• MalfunctionApr 20, 2026Contamination

  KORU MEDICAL BECAME AWARE THAT, DURING INITIAL INCOMING INSPECTION AT A CUSTOMER WAREHOUSE IN JAPAN, UNIDENTIFIED BLACK DEBRIS OR CONTAMINATION WAS FOUND INSIDE EIGHT SEALED HIGH-FLO NEEDLE SET POUCHES AND ONE SEALED PRECISION FLOW RATE TUBING POUCH. ADDITIONALLY, TWO POUCHES FROM HIGH-FLO NEEDLE SET RMS12414/LOT N.86873 WERE FOUND TO BE DAMAGED, POTENTIALLY COMPROMISING THE STERILE BARRIER. MEDICAL DEVICE REPORTS (MDRS) ARE BEING FILED FOR EACH AFFECTED DEVICE MALFUNCTION AND LOT. MDR 1318360-2026-00009 IS BEING FILED DUE TO CONTAMINATION OF FOUR POUCHES ASSOCIATED WITH HIGH-FLO NEEDLE SET RMS22409/LOT N.25D32N. MDR 1318360-2026-00011 IS BEING FILED DUE TO DELIVERY OF (POTENTIALLY) UNSTERILE PRODUCTS OF TWO POUCHES ASSOCIATED WITH HIGH-FLO NEEDLE SET RMS12414/LOT N.86873. MDR 1318360-2026-00012 IS BEING FILED DUE TO CONTAMINATION OF ONE POUCH ASSOCIATED WITH HIGH-FLO NEEDLE SET RMS22414/LOT N.86872. MDR 1318360-2026-00013 IS BEING FILED DUE TO CONTAMINATION OF ONE POUCH ASSOCIATED WITH PRECISION FLOW RATE TUBING FEXT/LOT T.87065. MDR 1318360-2026-00014 IS BEING FILED DUE TO CONTAMINATION OF TWO POUCHES ASSOCIATED WITH HIGH-FLO NEEDLE SET RMS32409/LOT N.25F49N. THE CUSTOMER PROVIDE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24932043 ↗
• MalfunctionApr 20, 2026Delivered as Unsterile Product

  KORU MEDICAL BECAME AWARE THAT, DURING INITIAL INCOMING INSPECTION AT A CUSTOMER WAREHOUSE IN JAPAN, UNIDENTIFIED BLACK DEBRIS OR CONTAMINATION WAS FOUND INSIDE EIGHT SEALED HIGH-FLO NEEDLE SET POUCHES AND ONE SEALED PRECISION FLOW RATE TUBING POUCH. ADDITIONALLY, TWO POUCHES FROM HIGH-FLO NEEDLE SET RMS12414/LOT N.86873 WERE FOUND TO BE DAMAGED, POTENTIALLY COMPROMISING THE STERILE BARRIER. MEDICAL DEVICE REPORTS (MDRS) ARE BEING FILED FOR EACH AFFECTED DEVICE MALFUNCTION AND LOT. MDR 1318360-2026-00009 IS BEING FILED DUE TO CONTAMINATION OF FOUR POUCHES ASSOCIATED WITH HIGH-FLO NEEDLE SET RMS22409/LOT N.25D32N. MDR 1318360-2026-00010 IS BEING FILED DUE TO CONTAMINATION OF ONE POUCH ASSOCIATED WITH HIGH-FLO NEEDLE SET RMS12414/LOT N.86873. MDR 1318360-2026-00012 IS BEING FILED DUE TO CONTAMINATION OF ONE POUCH ASSOCIATED WITH HIGH-FLO NEEDLE SET RMS22414/LOT N.86872. MDR 1318360-2026-00013 IS BEING FILED DUE TO CONTAMINATION OF ONE POUCH ASSOCIATED WITH PRECISION FLOW RATE TUBING FEXT/LOT T.87065. MDR 1318360-2026-00014 IS BEING FILED DUE TO CONTAMINATION OF TWO POUCHES ASSOCIATED WITH HIGH-FLO NEEDLE SET RMS32409/LOT N.25F49N. THE CUSTOMER PROVIDED PHOTOS OF THE POUCHES CONFIRMIN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24932042 ↗
• MalfunctionApr 20, 2026Contamination

  KORU MEDICAL BECAME AWARE THAT, DURING INITIAL INCOMING INSPECTION AT A CUSTOMER WAREHOUSE IN JAPAN, UNIDENTIFIED BLACK DEBRIS OR CONTAMINATION WAS FOUND INSIDE EIGHT SEALED HIGH-FLO NEEDLE SET POUCHES AND ONE SEALED PRECISION FLOW RATE TUBING POUCH. ADDITIONALLY, TWO POUCHES FROM HIGH-FLO NEEDLE SET RMS12414/LOT N.86873 WERE FOUND TO BE DAMAGED, POTENTIALLY COMPROMISING THE STERILE BARRIER. MEDICAL DEVICE REPORTS (MDRS) ARE BEING FILED FOR EACH AFFECTED DEVICE MALFUNCTION AND LOT. MDR IS BEING FILED DUE TO CONTAMINATION OF FOUR POUCHES ASSOCIATED WITH HIGH-FLO NEEDLE SET RMS22409/LOT N.25D32N. MDR 1318360-2026-00010 IS BEING FILED DUE TO CONTAMINATION OF ONE POUCH ASSOCIATED WITH HIGH-FLO NEEDLE SET RMS12414/LOT N.86873. MDR 1318360-2026-00011 IS BEING FILED DUE TO DELIVERY OF (POTENTIALLY) UNSTERILE PRODUCTS OF TWO POUCHES ASSOCIATED WITH HIGH-FLO NEEDLE SET RMS12414/N.86873. MDR 1318360-2026-00012 IS BEING FILED DUE TO CONTAMINATION OF ONE POUCH ASSOCIATED WITH HIGH-FLO NEEDLE SET RMS22414/N.86872. MDR 1318360-2026-00013 IS BEING FILED DUE TO CONTAMINATION OF ONE POUCH ASSOCIATED WITH PRECISION FLOW RATE TUBING FEXT/T.87065. MDR 1318360-2026-00014 IS BEING FILED DUE TO CONTAMINA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24928041 ↗
• MalfunctionSep 9, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  KORU MEDICAL WAS MADE AWARE THAT DURING INITIAL INCOMING INSPECTION AT A CUSTOMER WAREHOUSE IN JAPAN, UNIDENTIFIED BLACK DEBRIS/CONTAMINANT WAS FOUND INSIDE A SEALED STERILE NEEDLE SET POUCH INVOLVING RMS32409/LOT N.25B05N. MDR 1318360-2025-00020 IS BEING FILED FOR RMS32409/LOT N.25B05N. SUBSEQUENTLY, THE JAPANESE WAREHOUSE PERSONNEL COMPLETED INSPECTION ON THE REMAINING INVENTORY. UPON COMPLETION, AN ADDITIONAL SEALED POUCH WAS FOUND TO CONTAIN UNIDENTIFIED BLACK DEBRIS/CONTAMINANT INVOLVING RMS32414/LOT N.87033. THE CUSTOMER PROVIDED PHOTOS OF THE POUCHES CONFIRMING THE COMPLAINT. THERE WAS NO PATIENT INVOLVEMENT. A REVIEW OF THE DEVICE HISTORY RECORD FOR RMS32414/LOT N.87033 WAS PERFORMED AND NO NONCONFORMANCES OR ABERRANT CONDITIONS WERE NOTED. HIGH-FLO NEEDLE SETS ARE MANUFACTURED AND SEALED INTO THEIR PRIMARY STERILE BARRIER PACKAGING IN A CONTROLLED ENVIRONMENT. IN ADDITION, HIGH-FLO NEEDLE SETS ARE STERILIZED USING GAMMA IRRADIATION WHICH IS A HIGHLY PENETRATING AND EFFECTIVE STERILIZATION MODALITY. FURTHERMORE, VALIDATION OF THE STERILIZATION METHOD WAS PERFORMED USING A CONSERVATIVE METHOD (VDMAX25) WHICH PROVIDES A SAFETY MARGIN OVER ALTERNATE ACCEPTABLE VALIDATION METHO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23006864 ↗
• MalfunctionSep 9, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  KORU MEDICAL WAS MADE AWARE THAT DURING INITIAL INCOMING INSPECTION AT A CUSTOMER WAREHOUSE IN JAPAN, UNIDENTIFIED BLACK DEBRIS/CONTAMINANT WAS FOUND INSIDE A SEALED STERILE NEEDLE SET POUCH INVOLVING RMS32409/LOT N.25B05N. SUBSEQUENTLY, THE JAPANESE WAREHOUSE PERSONNEL COMPLETED INSPECTION ON THE REMAINING INVENTORY. UPON COMPLETION, AN ADDITIONAL SEALED POUCH WAS FOUND TO CONTAIN UNIDENTIFIED BLACK DEBRIS/CONTAMINANT INVOLVING RMS32414/LOT N.87033. MDR 1318360-2025-00021 IS BEING FILED FOR RMS32414/LOT N.87033. THE CUSTOMER PROVIDED PHOTOS OF THE POUCHES CONFIRMING THE COMPLAINT. THERE WAS NO PATIENT INVOLVEMENT. A REVIEW OF THE DEVICE HISTORY RECORD FOR RMS32409/LOT N.25B05N WAS PERFORMED AND NO NONCONFORMANCES OR ABERRANT CONDITIONS WERE NOTED. HIGH-FLO NEEDLE SETS ARE MANUFACTURED AND SEALED INTO THEIR PRIMARY STERILE BARRIER PACKAGING IN A CONTROLLED ENVIRONMENT. IN ADDITION, HIGH-FLO NEEDLE SETS ARE STERILIZED USING GAMMA IRRADIATION WHICH IS A HIGHLY PENETRATING AND EFFECTIVE STERILIZATION MODALITY. FURTHERMORE, VALIDATION OF THE STERILIZATION METHOD WAS PERFORMED USING A CONSERVATIVE METHOD (VDMAX25) WHICH PROVIDES A SAFETY MARGIN OVER ALTERNATE ACCEPTABLE VALIDATION METHO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23006863 ↗
• MalfunctionFeb 25, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  ON 28-JAN-2025 KORU MEDICAL RECEIVED 30 NEEDLE SETS (3 BOXES) OF RMS32614 (HIGH-FLO NEEDLE SET 26 GAUGE NEEDLE SETS - 3 NEEDLES - 14 MM) LOT N.86417 FROM A CUSTOMER UNDER A RETURN MATERIAL AUTHORIZATION. THERE WAS NO PATIENT INVOLVEMENT. DURING QUALITY CONTROL INSPECTION OF THE 30 NEEDLE SETS PERFORMED ON 29-JAN-2025, 2 NEEDLE SETS WERE FOUND CONTAMINATED WITH BLACK DEBRIS AND WHAT APPEARED TO BE HAIR. KORU INITIATED AN INTERNAL NON-CONFORMANCE REPORT TO INVESTIGATE. IN ADDITION, AN INTERNAL QUALITY ALERT WAS INITIATED TO INFORM INTERNAL PERSONNEL OF THE NON-CONFORMANCE. KORU MEDICAL IS CURRENTLY INVESTIGATING THIS EVENT. THIS EVENT MEETS THE REQUIREMENTS FOR FDA REPORTABILITY; HOWEVER, SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, MANUFACTURER OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21458437 ↗
• MalfunctionOct 24, 2024Fail-Safe Did Not Operate; Fail-Safe Did Not Operate

  KORU MEDICAL BECAME AWARE OF 2 NEEDLE STICK REPORTS INVOLVING KORU HIGH FLO SUBCUTANEOUS SAFETY NEEDLE SETS. IN BOTH CASES, THE NEEDLE SETS HAD BEEN USED ON PATIENTS. MDR 1318360-2024-00008 IS BEING FILED FOR NURSE #1, NEEDLE STICK/PUNCTURE REPORT. ADDITIONAL INFORMATION WAS RECEIVED FOR NURSE#2 ON (B)(6) 2024 STATING THE NURSE REMOVED THE INFUSION NEEDLES FROM THE PATIENT AND EACH NEEDLE WAS SNAPPED SHUT UPON REMOVAL (HEARD THE SNAP). WHILE DISPOSING OF THE INFUSION SET, ONE OF THE NEEDLES OPENED UP AND THE NURSE WAS PUNCTURED ON THE RIGHT INDEX FINGER. THE DATE OF OCCURRENCE FOR THIS EVENT IS (B)(6) 2024. MDR 1318360-2024-00009 IS BEING FILED FOR THE FIRST OCCURRENCE INVOLVING NURSE #2. WHILE TEACHING THE PATIENT THE FOLLOWING DAY ((B)(6) 2024), ALL NEEDLE WINGS AUDIBLY SNAPPED SHUT AND ONE REOPENED AFTER REMOVAL AND SNAPPING. A NEEDLE STICK DID NOT OCCUR IN THIS CASE. THIS MDR IS BEING FILED FOR THE SECOND OCCURRENCE WITH NURSE #2. THE NURSE WAS WEARING PPE (GLOVES) AT THE TIME THE EVENTS OCCURRED. THE NURSE FOLLOWED THE COMPANY'S PROTOCOL FOR REPORTING, EVALUATION, ETC. NO ADVERSE EVENT OUTCOMES WERE REPORTED TO HAVE OCCURRED. THE INITIAL REPORTER DID NOT PROVIDE ANY IDENTIFYIN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20528469 ↗
• MalfunctionOct 24, 2024Fail-Safe Did Not Operate; Fail-Safe Did Not Operate

  KORU MEDICAL BECAME AWARE OF 2 NEEDLE STICK REPORTS INVOLVING KORU HIGH FLO SUBCUTANEOUS SAFETY NEEDLE SETS. IN BOTH CASES, THE NEEDLE SETS HAD BEEN USED ON PATIENTS. MDR 1318360-2024-00008 IS BEING FILED FOR NURSE #(B)(4), NEEDLE STICK/PUNCTURE REPORT. ADDITIONAL INFORMATION WAS RECEIVED FOR NURSE#(B)(4) ON (B)(6)2024 STATING THE NURSE REMOVED THE INFUSION NEEDLES FROM THE PATIENT AND EACH NEEDLE WAS SNAPPED SHUT UPON REMOVAL (HEARD THE SNAP). WHILE DISPOSING OF THE INFUSION SET, ONE OF THE NEEDLES OPENED UP AND THE NURSE WAS PUNCTURED ON THE RIGHT INDEX FINGER. THE DATE OF OCCURRENCE FOR THIS EVENT IS (B)(6)2024. WHILE TEACHING THE PATIENT THE FOLLOWING DAY ((B)(6)2024), ALL NEEDLE WINGS AUDIBLY SNAPPED SHUT AND ONE REOPENED AFTER REMOVAL AND SNAPPING. A NEEDLE STICK DID NOT OCCUR IN THIS CASE. MDR 1318360-2024-00010 IS BEING FILED FOR THE SECOND OCCURRENCE WITH NURSE #(B)(4). THE NURSE WAS WEARING PPE (GLOVES) AT THE TIME THE EVENTS OCCURRED. THE NURSE FOLLOWED THE COMPANY'S PROTOCOL FOR REPORTING, EVALUATION, ETC. NO ADVERSE EVENT OUTCOMES WERE REPORTED TO HAVE OCCURRED. THE INITIAL REPORTER DID NOT PROVIDE ANY IDENTIFYING INFORMATION FOR THE NURSE DUE TO CONFIDENTIALITY. THE L

  Patient problems: Needle Stick/Puncture

  MAUDE report 20527801 ↗
• MalfunctionOct 24, 2024Fail-Safe Did Not Operate; Fail-Safe Did Not Operate

  KORU MEDICAL BECAME AWARE OF 2 NEEDLE STICK REPORTS INVOLVING KORU HIGH FLO SUBCUTANEOUS SAFETY NEEDLE SETS. IN BOTH CASES, THE NEEDLE SETS HAD BEEN USED ON PATIENTS. ADDITIONAL INFORMATION WAS PROVIDED FOR NURSE#1 STATING THE NEEDLE STICK OCCURRED DUE TO THE PATIENT NOT CLOSING THEM CORRECTLY AND WHILE THE NURSE WAS DISPOSING THEM IN THE SHARPS CONTAINER, THE NURSE'S LEFT POINTER FINGER WAS PUNCTURED. THE NURSE WAS WEARING PPE (GLOVES) AT THE TIME THE EVENT OCCURRED. THE NURSE FOLLOWED THE COMPANY'S PROTOCOL FOR REPORTING, EVALUATION, ETC. NO ADVERSE EVENT OUTCOMES WERE REPORTED TO HAVE OCCURRED. THE INITIAL REPORTER DID NOT PROVIDE ANY IDENTIFYING INFORMATION FOR THE NURSE DUE TO CONFIDENTIALITY. A LOT NUMBER FOR THE NEEDLE SET WAS NOT PROVIDED HOWEVER THE SET USED WAS A KORU HIGH-FLO 24 GAUGE NEEDLE SET - 4 NEEDLES - 12 MM. KORU MEDICAL IS CURRENTLY INVESTIGATING THIS EVENT. THIS EVENT MEETS THE REQUIREMENTS FOR FDA REPORTABILITY; HOWEVER, SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, MANUFACTURER OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

  Patient problems: Needle Stick/Puncture

  MAUDE report 20527407 ↗
• MalfunctionApr 21, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

  ON (B)(6) 2022, KORU MEDICAL WAS MADE AWARE THAT DURING INCOMING INSPECTION AT A CUSTOMER WAREHOUSE IN (B)(4) AN INSECT WAS FOUND INSIDE A SEALED STERILE NEEDLE SET POUCH. THE TEAM AT THE (B)(4) WAREHOUSE TESTED THE POUCH WITH THE DEBRIS INSIDE AND VERIFIED VIA HAND PRESSURE THAT THE BAG WAS IN FACT SEALED. SUBSEQUENTLY, THE (B)(4) WAREHOUSE CONDUCTED A 100% INSPECTION ON THE REMAINING INVENTORY FROM MODEL RMS22609/LOT N.80137. UPON COMPLETION, AN ADDITIONAL SEALED POUCH WAS FOUND TO CONTAIN AN UNIDENTIFIED BLACK CONTAMINANT. ADDITIONAL INFORMATION RECEIVED FROM THE INITIAL REPORTER STATED LOT N.80137 CONTAINED 1000 POUCHES. OF THE 1000, 11 POUCHES WERE PROVIDED FOR CLINICAL USE ON STUDY SUBJECTS ON (B)(6) 2022. AT THIS TIME, THE REMAINING 989 BAGS FROM THE LOT ARE QUARANTINED IN THE CUSTOMER'S INVENTORY SYSTEM. A RETURN MATERIAL AUTHORIZATION WAS CREATED FOR RETURN OF THE 2 POUCHES TO KORU MEDICAL FOR FURTHER EVALUATION. THE PRODUCTS ARE PENDING RETURN TO KORU MEDICAL AT THIS TIME. KORU MEDICAL COMPLETED AN INITIAL INVESTIGATION OF THE REPORTED INCIDENT. A SUMMARY OF THE RESULTS IS AS FOLLOWS: THE NEEDLE SETS WERE SHIPPED TO (B)(4) WITH THE INTENTION OF SUPPORTING A CLINICAL STUDY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14166645 ↗
• MalfunctionApr 21, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

  ON 23-MAR-2022, KORU MEDICAL WAS MADE AWARE THAT DURING INCOMING INSPECTION AT A CUSTOMER WAREHOUSE IN (B)(6), JAPAN AN INSECT WAS FOUND INSIDE A SEALED STERILE NEEDLE SET POUCH. THE TEAM AT THE JAPANESE WAREHOUSE TESTED THE POUCH WITH THE DEBRIS INSIDE AND VERIFIED VIA HAND PRESSURE THAT THE BAG WAS IN FACT SEALED. SUBSEQUENTLY, THE JAPANESE WAREHOUSE CONDUCTED A 100% INSPECTION ON THE REMAINING INVENTORY FROM MODEL RMS22609/LOT N.80137. UPON COMPLETION, AN ADDITIONAL SEALED POUCH WAS FOUND TO CONTAIN AN UNIDENTIFIED BLACK CONTAMINANT. ADDITIONAL INFORMATION RECEIVED FROM THE INITIAL REPORTER STATED LOT N.80137 CONTAINED 1000 POUCHES. OF THE 1000, 11 POUCHES WERE PROVIDED FOR CLINICAL USE ON STUDY SUBJECTS ON (B)(6) 2022. AT THIS TIME, THE REMAINING 989 BAGS FROM THE LOT ARE QUARANTINED IN THE CUSTOMER'S INVENTORY SYSTEM. A RETURN MATERIAL AUTHORIZATION WAS CREATED FOR RETURN OF THE 2 POUCHES TO KORU MEDICAL FOR FURTHER EVALUATION. THE PRODUCTS ARE PENDING RETURN TO KORU MEDICAL AT THIS TIME. KORU MEDICAL COMPLETED AN INITIAL INVESTIGATION OF THE REPORTED INCIDENT. A SUMMARY OF THE RESULTS IS AS FOLLOWS: THE NEEDLE SETS WERE SHIPPED TO JAPAN WITH THE INTENTION OF SUPPORTING A CLIN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14166644 ↗