N/A 305122Recalls & reported problems

Summary

The FDA's MAUDE database contains 71 adverse event reports that list this exact device (DI 00382903051229), received between Nov 8, 2017 and Mar 30, 2026 — classified as 6 injuries, 65 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (12 reports).

3 other recalls cover devices cleared under the same FDA submission (K021475); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 71 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 30, 2026Contamination

  IT WAS REPORTED BY A CUSTOMER THAT THEY DISCOVERED GLUE ON THE NEEDLE THAT DOES NOT COME OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24714495 ↗
• MalfunctionFeb 24, 2026Contamination

  IT IS REPORTED FOREIGN MATTER. DESCRIPTION: NOT ABLE TO USE BENT HAS A COUPLE OF ONE THAT HAS CONTAMINATION, METAL SHAVINGS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24428720 ↗
• MalfunctionFeb 28, 2025Labelling, Instructions for Use or Training Problem; Packaging Problem; Labelling, Instructions for Use or Training Problem; Packaging Problem

  NO ADDITIONAL INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21492647 ↗
• MalfunctionNov 22, 2024Material Puncture/Hole; Material Puncture/Hole

  MATERIAL # 305122 BATCH # 4060100 ISSUE: PT WAS RECAPPING NEEDLE AND HAD A NEEDLE STICK WHEN NEEDLE PIERCED THROUGH SAFETY SHEILD. PT HARM PICTURE IS AVAILABLE WAS THE NEEDLE CONTAMINATED WITH BODILY FLUIDS THAT WERE NOT YOUR OWN? NO IT WAS NOT. WERE THERE ANY DIAGNOSTICS PERFORMED AS A RESULT OF THE SOILED NEEDLE STICK? IF YES, WHAT DIAGNOSTICS WERE PERFORMED? NO, NO DIAGNOSTICS WERE PERFORMED. WAS ANY MEDICAL INTERVENTION REQUIRED? IF YES, PLEASE DESCRIBE WHAT TREATMENT WAS PROVIDED. NO, NO MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: Needle Stick/Puncture

  MAUDE report 20757050 ↗
• MalfunctionOct 24, 2024Leak/Splash; Leak/Splash

  MATERIAL: 305122, BATCH#: 3055928. IT WAS REPORTED BY THE CUSTOMER THAT THE TIME OF THE INJECTION IN THE PATIENT, THE SOLUTION WAS SPRAYING OUT THE PLASTIC HUB (BLUE PLASTIC) SIDEWAYS. THIS WAS ALSO NOTED BY OTHER STAFF ON 4 OTHER OCCASIONS. RCC RECEIVED A COMPLAINT VIA EMAIL. CHC COMPLAINT REFERENCE#: (B)(4). CORRESPONDENCE LANGUAGE: ENGLISH. CAT# OF PRODUCT BEING COMPLAINED: BD305122. DESCRIPTION OF PRODUCT: NEEDLE HYPO BEVEL 25GX5/8IN ST 100EA/BX 10BX/CA. LOT OR S/N: (B)(6). COMPLAINT CATEGORY: FAIL TO FUNCTION / DEFECTIVE. RGA NUMBER: REPORTABLE: NO. INCIDENT DATE: ON (B)(6) 1980. HOSPITAL COMPLAINT REFERENCE#: DETAILS OF COMPLAINT (REPORTED ISSUE): AT THE TIME OF THE INJECTION IN THE PATIENT, THE SOLUTION WAS SPRAYING OUT THE PLASTIC HUB (BLUE PLASTIC) SIDEWAYS. THIS WAS ALSO NOTED BY OTHER STAFF ON 4 OTHER OCCASIONS. SUPPLIER - PLEASE ADVISE IF YOU WOULD LIKE THE PRODUCT BACK AS A SAMPLE FOR INVESTIGATION. OUR CUSTOMER CARE TEAM WOULD LIKE TO KNOW IF THEY CAN PROCEED T CREDIT THE ITEM. INCIDENT DATE UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20521596 ↗
• InjuryJul 29, 2024Crack; Crack

  MATERIAL#: 305122. BATCH#: 3055928. IT WAS REPORTED BY THE CUSTOMER THAT THE NEEDLE HUB WAS CRACKED AND WHEN STAFF MEMBER WENT TO REMOVE/CHANGE THE NEEDLE, IT PUNCTURED THEIR GLOVE, CUT THEM AND DREW BLOOD. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. PRODUCT INFORMATION PRODUCT CODE: 305122. PRODUCT DESCRIPTION: NEEDLE HYPO 25 X 5/8IN RB BX/100 LOT/SERIAL #: 3055928. EXPIRY DATE: 2028-04-30. PROBLEM INFORMATION: PRODUCT CONCERN TICKET NUMBER: (B)(4) DATE OF INCIDENT: (B)(6) 2023 CONCERN DESCRIPTION: NEEDLE HUB WAS CRACKED AND WHEN STAFF MEMBER WENT TO REMOVE/CHANGE THE NEEDLE, IT PUNCTURED THEIR GLOVE, CUT THEM AND DREW BLOOD. OCCURRENCES: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19849564 ↗
• MalfunctionJul 7, 2024Material Puncture/Hole; Material Puncture/Hole

  MATERIAL: 305122 BATCH#: 3145665 IT WAS REPORTED BY THE CUSTOMER THAT NEEDLESTICK INJURY RISK DUE TO NEEDLE PIERCING THROUGH CAP. RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. PRODUCT CODE: 305122 PRODUCT DESCRIPTION: PRECISION GLIDE NEEDLE ¿ 25G X 5/8¿ LOT #: 3145665 FIRST REPORTED JUNE 20TH 2024. COMPLAINT: NEEDLESTICK INJURY RISK DUE TO NEEDLE PIERCING THROUGH CAP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19686684 ↗
• MalfunctionMay 28, 2024Complete Blockage; Obstruction of Flow; Complete Blockage; Obstruction of Flow

  NO ADDITIONAL INFORMATION RECEIVED. MATERIAL#: 305122. BATCH#: 3055929. IT WAS REPORTED BY THE CUSTOMER THAT CUSTOMER EXPERIENCING ISSUE WITH THE NEEDLE NOW LETTING LIQUID THROUGH REQUIRING YOU TO PUSH THE SYRINGE HARD THEN IT POPS OFF. IT ALSO HAS LIQUID LEAKING THROUGH. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. INJURIES OR ADVERSE EVENT: NO. ITEM: 305122. QUANTITY AFFECTED: 2 BX. SERIAL/LOT NUMBER: (B)(6). PO : (B)(4). ARE ANY SAMPLES AVAILABLE FOR RETURN? YES. REPORTED ISSUE: CUSTOMER EXPERIENCING ISSUE WITH THE NEEDLE NOW LETTING LIQUID THROUGH REQUIRING YOU TO PUSH THE SYRINGE HARD THEN IT POPS OFF. IT ALSO HAS LIQUID LEAKING THROUGH. COMMENTS ON 24/05/2024. MAY 15TH 2024.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19410651 ↗
• MalfunctionMay 28, 2024Leak/Splash; Leak/Splash

  NO ADDITIONAL INFORMATION RECEIVED. MATERIAL#: 305122. BATCH#: 3055929. IT WAS REPORTED BY THE CUSTOMER THAT CUSTOMER EXPERIENCING ISSUE WITH THE NEEDLE NOW LETTING LIQUID THROUGH REQUIRING YOU TO PUSH THE SYRINGE HARD THEN IT POPS OFF. IT ALSO HAS LIQUID LEAKING THROUGH. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. INJURIES OR ADVERSE EVENT: NO ITEM: 305122. QUANTITY AFFECTED: 2 BX. SERIAL/LOT NUMBER: (B)(6) PO : (B)(4). ARE ANY SAMPLES AVAILABLE FOR RETURN? YES . REPORTED ISSUE: CUSTOMER EXPERIENCING ISSUE WITH THE NEEDLE NOW LETTING LIQUID THROUGH REQUIRING YOU TO PUSH THE SYRINGE HARD THEN IT POPS OFF. IT ALSO HAS LIQUID LEAKING THROUGH. COMMENTS ON 24/05/2024. MAY 15TH 2024.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19410501 ↗
• MalfunctionApr 10, 2024Complete Blockage; Complete Blockage

  MATERIAL # 305122 , LOT # 1300339. IT WAS REPORTED BY CUSTOMER THAT THE NEEDLE IS DEMONSTRATING A POSSIBLE DEFECT. THEY ARE HAVING ISSUES GETTING INJECTIONS TO PASS THROUGH THE NEEDLE AND HAVE NEVER HAD THIS ISSUE BEFORE. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. INJURIES OR ADVERSE EVENT: NO. MEDLINE REFERENCE #: (B)(4). ITEM: 305122. QUANTITY AFFECTED: (B)(4) BX. SERIAL/LOT NUMBER: (B)(6). PO #: (B)(4). ARE ANY SAMPLES AVAILABLE FOR RETURN? YES. REPORTED ISSUE PER CUSTOMER: 4-2 CUSTOMER SAID THE NEEDLE IS DEMONSTRATING A POSSIBLE DEFECT. THEY ARE HAVING ISSUES GETTING INJECTIONS TO PASS THROUGH THE NEEDLE AND HAVE NEVER HAD THIS ISSUE BEFORE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19078244 ↗
• MalfunctionApr 2, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  NO ADDITIONAL INFORMATION RECEIVED MATERIAL #:BD305122 BATCH#:2363623 IT WAS REPORTED BY CUSTOMER THAT THE DOCTOR INJECTED THE NEEDLE ON A CLEAN VIAL OF ALLERGY SERUM, AFTER THE EXTRACTION OF THE SERUM, THE DOCTOR PUT THE CAP BACK THEN PUSHES SOME AIR OUT OF THE NEEDLE, THAT'S WHEN THE STAIN CAME OUT OF THE NEEDLE INTO THE CAP. IT LOOKS LIKE A RUSTIC STAIN. DUE TO THE STAIN, THE ALLERGY SERUM WAS COMPROMISED, HENCE NEW SERUM IS NEEDED WHICH COSTS A LOT. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. CHC COMPLAINT REFERENCE #: (B)(4). CUSTOMER (HOSPITAL) NAME: (B)(6). CORRESPONDENCE LANGUAGE: ENGLISH CAT# OF PRODUCT BEING COMPLAINED: BD305122 DESCRIPTION OF PRODUCT: NEEDLE HYPO BEVEL 25GX5/8IN ST 100EA/BX 10BX/CA LOT OR S/N: 2363623 COMPLAINT CATEGORY: FAIL TO FUNCTION / DEFECTIVE REPORTABLE: NO INCIDENT DATE: 25 MAR 2024 HOSPITAL COMPLAINT REFERENCE #: DETAILS OF COMPLAINT (REPORTED ISSUE): CUSTOMER ADVISED:"ONE OF OUR DOCTORS TOOK A SEALED CLEAN 25G5/8 NEEDLE WITH LOT NUMBER 2363623 EXP: 2028-01-31, THE DOCTOR INJECTED THE NEEDLE ON A CLEAN VIAL OF ALLERGY SERUM, AFTER THE EXTRACTION OF THE SERUM, THE DOCTOR PUT THE CAP BACK THEN PUSHES SOME AIR OUT OF THE NEEDLE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19019478 ↗
• MalfunctionMar 26, 2024Contamination; Incomplete or Missing Packaging; Contamination; Incomplete or Missing Packaging

  NO ADDITIONAL INFORMATION RECEIVED. MATERIAL#: 305122, BATCH NUMBER#: 3145665. IT WAS REPORTED BY CUSTOMER THAT THEY OPENED A BOX OF 25G X 5/8¿ BD PRECISIONGLIDE NEEDLE AND THERE WAS AN UNPACKAGED NEEDLE IN THE NEW BOX, THE CAP WAS STILL ON. NEEDLE WAS DIRTY. VERBATIM#: GOOD MORNING, I HAD A STAFF MEMBER OPEN A BOX OF 25G X 5/8¿ BD PRECISIONGLIDE NEEDLE AND THERE WAS AN UNPACKAGED NEEDLE IN THE NEW BOX, THE CAP WAS STILL ON. NEEDLE WAS DIRTY. LOT-3145665. EXP-6/30/28. JUST WANTED TO MAKE YOU AWARE. RESPONSE: ON 3/15/24.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18977706 ↗
• MalfunctionDec 27, 2023Defective Component; Defective Component

  MATERIALS#: 305122 BATCH#: 3024981. IT WAS REPORTED BY THE CUSTOMER THAT THERE IS A PINPOINT HOLE IN THE PLASTIC BARREL PORTION ATTACHED TO THE NEEDLE. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. CLINIC REPORTED: ¿I HAVE HAD TO DATE 2 NEEDLES FROM THIS BOX OF NEEDLES, WHERE THERE IS A PIN POINT HOLE IN THE PLASTIC BARREL PORTION ATTACHED TO THE NEEDLE, SUCH THAT WHEN I GO TO INJECT MEDICATION THROUGH THE NEEDLE, THE LIQUID MEDICATION SHOOTS OUT THE SIDE OF THE HUB. I HAVE TWO OTHER BOXES OF NEEDLES IN ADDITION TO MY CURRENT OPEN BOX, WITH THE SAME LOT NUMBER AND EXPIRATION DATE AND BAR CODES.¿ MFG CODE: 305122. DESCRIPTION: NEEDLE BD 25G X 5/8IN - 100`S. LOT: 3024981. EXPIRY: 3/31/2028. WDDC PO: POM0105109 / 5-23-2023. (B)(6). I HAVE PROVIDED THE CLINICS INVOICE ADDITIONALLY, AS THEY HAVE 2 BOXES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18397593 ↗
• MalfunctionNov 7, 2023Leak/Splash; Leak/Splash

  (B)(4).ADDITIONAL INFORMATION RECEIVED.   (B)(6) 2023. AS INDICATED WITHIN THE ORIGINAL COMPLAINT SENT TO YOU ¿ THIS COMPLAINT IS NOT RELATED TO ANY PATIENT OR ADVERSE EFFECT. - PLEASE PROVIDE OCCURRENCE DATE. NOT PROVIDED BY CUSTOMER .- WHAT MEDICATION WAS USED DURING THE INCIDENT? NOT APPLICABLE .- IS THERE ANY ADVERSE EVENT ON PATIENT? NOT APPLICABLE .- IS THERE ANY MEDICAL INTERVENTION NEEDED DUE TO THE INCIDENT? NOT APPLICABLE - IS PHOTO/SAMPLE OR AVAILABLE FOR RETURN? IF YES, PLEASE CONFIRM YOUR ADDRESS FOR RETURN LABEL. NOT PROVIDED BY CUSTOMER. (B)(6) 2023. PLEASE PROVIDE OCCURRENCE DATE.(B)(6) 2023 DIFFERENT DAYS BECAUSE IT HAPPENS OFTEN. - WHAT MEDICATION WAS USED DURING THE INCIDENT? NO MEDICATION. - IS THERE ANY ADVERSE EVENT ON PATIENT? NO. - IS THERE ANY MEDICAL INTERVENTION NEEDED DUE TO THE INCIDENT? NO. - IS PHOTO/SAMPLE OR AVAILABLE FOR RETURN? IF YES, PLEASE CONFIRM YOUR ADDRESS FOR RETURN LABEL. YES I SEND YOU THE PHOTO BUT WE ALSO CAN SEND YOU SOME EXEMPLES. NOTE THAT WE USE THIS PRODUCT TO PROCESS RADIOACTIVITY SO IT IS A VERY BIG PROBLEM FOR US. THE ADDRESS TO RETURN LABEL IS 2655, AV DALTON , QUEBEC G1P3S8. (B)(6) 2023 NO WORRY, I HAVE MANY SAMPLES ON MY DES

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18082991 ↗
• MalfunctionNov 2, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  ADDITIONAL INFORMATION RECEIVED MAT#: 305122, BATCH#: 3055928. IT WAS REPORTED BY CUSTOMER THAT WHEN CUSTOMER OPENED NEW NEEDLE, FOUND IT TO HAVE MOISTURE AND BLACK MATERIAL IN NEEDLE HUB. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. PRODUCT INFORMATION. PRODUCT CODE: 305122. PRODUCT DESCRIPTION: NEEDLE HYPO 25 X 5/8IN. LOT/SERIAL #: (B)(6). EXPIRY DATE: 2028-04-30. PROBLEM INFORMATION OPENED NEW NEEDLE, FOUND IT TO HAVE MOISTURE AND BLACK MATERIAL IN NEEDLE HUB. OCCURRENCES: (B)(4) EACH. REPORTER INFORMATION REPORTER POSITION/DEPARTMENT: REGULATORY COMPLIANCE SAMPLE INFORMATION INCIDENT SAMPLES: 0. REPRESENTATIVE SAMPLES: (B)(6) EACH. NO ADVERSE EVENT REPORTED 24OCT2023. THE INCIDENT DATE WAS 04-OCT-2023. THE COMPLAINT SAMPLE IS NOT AVAILABLE FOR RETURN AS IT WAS DISCARDED UPON DISCOVERY OF THE CONTAMINANTS. THERE ARE HOWEVER, (B)(4) NEEDLES REMAINING OF THE (B)(4) BOX THAT ARE CURRENTLY QUARANTINED, AWAITING DISPOSITION. KINDLY, PLEASE ADVISE WITH REGARDS TO DISPOSITION AND REIMBURSEMENT. AVP WOULD ALSO BE INTERESTED IN ANY INVESTIGATIVE FINDINGS, IF/WHEN AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18054951 ↗
• MalfunctionOct 23, 2023Leak/Splash; Material Puncture/Hole; Leak/Splash; Material Puncture/Hole

  NO ADDITIONAL INFORMATION RECEIVED MATERIAL #: 305122 BATCH#: 3083970. IT WAS REPORTED BY CUSTOMER THAT LIQUID LEAKING OUT OF THE HUB, HOLES IN THE HUB. VERBATIM: RCC RECEIVED COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. GOOD AFTERNOON ¿ PLEASE FIND COMPLAINT ATTACHED REPORTED TO XXXX - LIQUID LEAKING OUT OF THE HUB ¿ HOLES IN THE HUB.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17984448 ↗
• MalfunctionOct 23, 2023Material Puncture/Hole; Defective Component; Material Puncture/Hole; Defective Component

  PR 9061274 ADDITIONAL INFORMATION RECEIVED MATERIAL #: 305122, BATCH #: 3055930. IT WAS REPORTED BY THE CUSTOMER THAT 2 BOXES OF 100 OF NEEDLE 25X5/8 RB STERILE HAD LIQUID LEAKING OUT OF THE HUB. VERBATIM: PLEASE FIND COMPLAINT ATTACHED REPORTED TO PENN VET FROM ANIMALS R SPECIAL. THE CLINIC REPORTS 2 BOXES OF 100 OF NEEDLE 25X5/8 RB STERILE (305122), LOT 3055930, EXP. 4/28 ¿ LIQUID LEAKING OUT OF THE HUB. MAY HAVE HOLE IN THE HUB. THE PO VEDCO RECEIVED THIS PRODUCT ON IS 106009. RESPONSE RECEIVED ON 16-OCT-2023: VIDEOS OF THE SITUATION HAVE BEEN SENT SEPARATELY: 1. ARE YOU ABLE TO PROVIDE THE DATE OF INCIDENT? APPROXIMATELY OCTOBER 9TH-12TH. 2. PLEASE DESCRIBE HOW WAS THE ISSUE FIRST NOTICED. VACCINATING A PATIENT AND STOCKING INVENTORY. 3. WHAT PROCEDURE WAS BEING PERFORMED? VACCINATING A PATIENT. 4. WHAT SOLUTION/MEDICATION WAS BEING USED? RABIES VACCINE. 5. WAS THE PROCEDURE COMPLETED AS PLANNED? WE REDREW THE VACCINE AND CHANGED OUT OUR DEFECTIVE NEEDLE AND COMPLETED THE PROCEDURE. 6. WAS THERE ANY PATIENT INVOLVEMENT? IF SO, WHAT WAS THE PATIENT OUTCOME? YES, THE PATIENT WAS NOT EFFECTIVE. 7. IS ANY SAMPLE AVAILABLE FOR INVESTIGATION? IF NO, CAN A PHOTO BE PROVIDED? YES, I SA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17984443 ↗
• InjuryAug 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT WHILE USING THE BD® NEEDLE 5/8 IN. SINGLE USE, STERILE A NEEDLE STICK OCCURED. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: WE RECENTLY HAD A NEEDLE STICK THAT RESULTED IN MEDICAL TREATMENT.

  Patient problems: Needle Stick/Puncture

  MAUDE report 17620782 ↗
• MalfunctionAug 17, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT 2 BD PRECISIONGLIDE¿ NEEDLES LEAKED AT THE HUB CONNECTION DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE BUYER ADVISED SHE HAS HAD: ¿TWO NEEDLES THAT ARE LEAKING SUBSTANCE WHERE THE NEEDLE AND HUB COMES TOGETHER. HASN'T HAD ANY OTHER NEEDLES WITH THIS ISSUE SO FAR.¿"

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17569346 ↗
• MalfunctionJul 20, 2023Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT 3 OF THE BD® NEEDLE 5/8 IN. SINGLE USE, STERILE HAD HOLES IN THE DEVICE. VERBATIM: INJURIES OR ADVERSE EVENT: NO. REPORTED ISSUE: HOLES IN THEM. WHERE WAS THE HOLES LOCATED ON THE DEVICE? ON THE BASE THAT¿S HOLDING THE NEEDLE .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17358233 ↗
• MalfunctionJul 20, 2023Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED WHILE USING THE BD® NEEDLE 5/8 IN. SINGLE USE, STERILE THERE WERE HOLES IN DEVICE. VERBATIM: INJURIES OR ADVERSE EVENT: NO. REPORTED ISSUE: HOLES IN THEM. WHERE WAS THE HOLES LOCATED ON THE DEVICE? ON THE BASE THAT¿S HOLDING THE NEEDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17358228 ↗
• MalfunctionMay 11, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED WHILE USING BD® NEEDLE 5/8 IN. SINGLE USE, STERILE, 25 G THERE WAS A DAMAGED NEEDLE HUB AND LEAKAGE OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: TO PREPARE FOR A NUCLEAR MEDICINE SCAN, NURSE ATTEMPTED TO INJECT 74-YEAR-OLD PATIENT WITH RADIOACTIVE MATERIAL. DUE TO A CRACK IN THE NEEDLE HUB, A SMALL AMOUNT OF MATERIAL LEAKED THROUGH THE CRACK AND TOUCHED THE PATIENT¿S SKIN BEFORE DRIPPING ONTO THE ARM OF THE CHAIR. THE SPILL WAS CONTAINED AND CLEANED ACCORDING TO HAZARDOUS SPILL PROTOCOL. THE SAME VOLUME OF MATERIAL WAS DRAWN UP, AND, THOUGH A SECOND VENIPUNCTURE, INJECTED INTO THE PATIENT.

  Patient problems: Chemical Exposure; Needle Stick/Puncture

  MAUDE report 16916942 ↗
• MalfunctionApr 26, 2023Contamination; Contamination

  IT WAS REPORTED THAT EXCESSIVE EPOXY WAS FOUND ON 7 BD PRECISIONGLIDE¿ NEEDLES BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "NCR REGARDING FOREIGN MATTER IN THE FOUND IN STERILE PACKAGING. WE FOUND ADDITIONAL FAILURE MODES DURING SORTING ACTIVITIES, INCLUDING MISSING NEEDLES ENTIRELY. WE HAVE 35 REJECTED CAPS... ON (B)(6) 2023, DURING INCOMING INSPECTION, FOREIGN MATTER WAS OBSERVED IN THE STERILE PACKAGE OF THE NEEDLE WHICH WAS GREATER THAN 0.15MM² SPECIFICATION (TPI-41 CHART REFERENCE OF FOREIGN MATTER). THE STATED NON-CONFORMANCE IS RELATED TO THE PRESENCE OF FOREIGN MATTER LARGER THAN 0.15MM2 SPECIFICATION IN THE STERILE PACKAGING OF P/N 3022 LOT # 2363623. THE FOREIGN MATTER IS EMBEDDED INTO THE CLEAR PROTECTIVE CAP AND IS NOT SUSPECTED TO MAKE CONTACT WITH THE NEEDLE. IN A CLINICAL SETTING, THE PROTECTOR IS REMOVED PRIOR TO INSERTION OF THE NEEDLE. IN A WORST-CASE SCENARIO, FOREIGN MATTER CONTAMINATION HAS THE POTENTIAL TO CAUSE INFECTION. FOREIGN MATERIAL (16). MISSING NEEDLE (12). EXCESSIVE MOLDING (7)".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16818150 ↗
• InjuryMar 25, 2023Break; Break

  IT WAS REPORTED THAT THE BD PRECISIONGLIDE¿ NEEDLES BROKE OFF DURING USE AND GOT LODGED IN ANIMAL. AN INCISION HAD TO BE MADE TO REMOVE THE NEEDLE TIP THAT WAS EMBEDDED IN THE MUSCLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NEEDLE BROKE OFF DURING USE AND GOT LODGED IN ANIMAL. INJURY: YES, DID HAVE TO MAKE INCISION OVER SITE AND THEN REMOVE THE NEEDLE TIP THAT WAS EMBEDDED IN MUSCLE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 16616535 ↗
• MalfunctionFeb 28, 2023Break; Material Puncture/Hole; Break; Material Puncture/Hole

  IT WAS REPORTED WHILE USING BD¿ NEEDLE 5/8 IN. SINGLE USE, STERILE, 25 G THE NEEDLE WAS BROKEN. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: A BROKEN SYRINGE NEEDLE.

  Patient problems: Needle Stick/Puncture

  MAUDE report 16457731 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K021475. One submission often covers many models, so check the product and lot details in each record.

• Z-0588-2021 · Nov 18, 2020 · Terminated
  BD PrecisionGlide Needle 30G x 1/2 (0.3 mm X 13mm) REF 305106 - Product Usage: used for general purpose injection and aspiration of fluids from vials, ampoules and parts of the bo
• Z-0207-2018 · May 31, 2017 · Terminated
  BD Precision Glide Needle 18G x 1 RB, Catalog 305195 Product Usage: These needles are intended for general purpose fluid injection/aspiration, infusion, venipuncture to obtain bl
• Z-1009-2012 · Oct 8, 2011 · Terminated
  BD 30G1/2" Precision Glide" Needle Needles are used for aspiration and injection of medications