Port Access Needle S02020-10Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00801741048722), received between Sep 6, 2018 and Apr 21, 2022 — classified as 22 malfunctions.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (4 reports).

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 21, 2022Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED "PACKAGE WITHOUT SEAL, EXPOSING THE MATERIAL TO EXTERNAL ENVIRONMENT." ON 01.APR.2022, DISTRIBUTOR PROVIDES THE FOLLOWING: WAS ISSUE NOTICED PRIOR, DURING OR AFTER USE? WAS PRODUCT USED EVEN THOUGH SITUATION WAS OBSERVED PRIOR IT? R: PRIOR USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14170262 ↗
• MalfunctionJan 27, 2021No Fail-Safe Mechanism

  CUSTOMER REPORTS THAT PROTECTIVE COVER IS MISSING. ON (B)(6) 2021- THE PROTECTIVE COVER WAS MISSING FROM THE NEEDLE ITSELF.

  Patient problems: No Patient Involvement

  MAUDE report 11238198 ↗
• MalfunctionJul 23, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED NEEDLE LEAKED PRIOR TO USE ON A PATIENT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10314936 ↗
• MalfunctionJun 10, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THE MINILOC NEEDLE HAD A BLACK SUBSTANCE IN THE TUBING.

  Patient problems: No Patient Involvement

  MAUDE report 10138854 ↗
• MalfunctionJun 10, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED MINILOC WITH LEAKAGE THROUGH INFUSION LINE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 10138337 ↗
• MalfunctionJun 10, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED MINILOC WITH LEAKAGE THROUGH INFUSION LINE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10138246 ↗
• MalfunctionJan 7, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED MINILOC WITH A LEAKAGE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9559953 ↗
• MalfunctionNov 14, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED VIA MS&S "PATIENT STATES THAT SHE HAS POWERPORT CLEARVUE ISP ON (B)(6)2019. SHE STATES THE FIRST MONTH ACCESS WAS STUCK X 10 TO ACCESS THE POWERPORT. SHE STATES THAT A CHEST X-RAY WAS DONE TO RULE OUT A FLIPPED PORT. PATIENT STATE THE X-RAY DID NOT SHOW A FLIPPED POWERPORT. SHE STATES THE POWERPORT IS NOT PERPENDICULAR AND CANNOT FEEL ALL 3 BUMPS ON THE POWERPORT. PATIENT STATES THAT AFTER 2 MONTHS AFTER PLACEMENT THE POWERPORT WAS ACCESSED WITH MINILOC SAFETY INFUSION SET S02020-10 AND LOT ASBSS0120 WAS USED TO ACCESS THE POWERPORT AND ON SEVERAL OCCASIONS "POPPED OUT OF THE PORT". SHE STATES THEY SWITCH NEEDLES AND SHE IS NOW USING POWERLOC MAX SAFETY INFUSION SET 0142075 WITH LOT ASDQS0241. AND THAT NEEDLE IS "POPPING OUT OF THE PORT." SHE STATES THE DRESSING IS INTACT WITH NEEDLE POPPING OUT. SHE STATES SHE HAS MANY ALLERGIES AND CAN ONLY USE THE IV3000 DRESSING. SHE STATES SHE STATES ACCESSED AT HOME. DENIES EXTREME MOVEMENT OF CHEST OR ARMS. MS&S SUGGESTED TO TRY A LONGER NEEDLE DUE TO THE POWERPORT NOT BEING PERPENDICULAR IN THE CHEST AND THE POWERPORT BEING SLANTED." THIS REPORT ADDRESSES THE MINILOC SAFETY INFUSION SET USED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9323859 ↗
• MalfunctionNov 6, 2019Activation Problem; Activation Problem

  IT WAS REPORTED THAT CUSTOMER REPORTS SECURITY SYSTEM ISSUE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9286787 ↗
• MalfunctionNov 1, 2019Activation Problem; Activation Problem

  IT WAS REPORTED THAT THE NEEDLE BENT WHEN INSERTED. SAFETY MECHANISM SLIPS OUT WHEN INSERTED. GRIP TO HOLD THE NEEDLE VERY SMALL AND WHEN HOLDING THE WINGS THE NEEDLE SLIPS BACK INTO THE SAFETY CAP.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9266894 ↗
• MalfunctionOct 30, 2019Contamination /Decontamination Problem; Device Contamination with Chemical or Other Material; Contamination /Decontamination Problem; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT PARTICLES WERE FOUND IN LUER LOCK. THE DEVICE WAS NOT USED ON A PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9256029 ↗
• MalfunctionJul 11, 2019Contamination /Decontamination Problem

  IT WAS REPORTED A MINILOC WITH RED COLOR AT THE TIP. ON (B)(6) 2019 - FOREIGN MATERIAL WAS FOUND ON THE RETURNED SAMPLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8782788 ↗
• MalfunctionJul 10, 2019Crack; Leak/Splash

  IT WAS REPORTED THAT THE EXTREMITY OF THE CANNULA WAS CRACKED. ON 6/20/2019, THE RETURNED SAMPLE LEAKED AT TUBE CONNECTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8777638 ↗
• MalfunctionApr 3, 2019Break

  IT WAS REPORTED BY THE CUSTOMER THAT THE SECURITY LOCK WAS BROKEN ON THE DEVICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8480439 ↗
• MalfunctionDec 7, 2018Contamination

  IT WAS REPORTED THAT IN THE PRODUCTION LINE, 1 UNIT OF NEEDLE MINILOC LOT ASBUS0197 PRESENTED SOME FLUID/LIQUID IN THE TUBE. THE UNIT WAS SEGREGATED, IDENTIFIED AND FORWARDED FOR SHIPMENT TO THE MANUFACTURER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8142062 ↗
• MalfunctionNov 15, 2018Contamination /Decontamination Problem

  IT WAS REPORTED HAIR INSIDE THE SEALED PACKAGE, MAKING THE MATERIAL IMPOSSIBLE TO USE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8076138 ↗
• MalfunctionSep 6, 2018Moisture or Humidity Problem

  IT WAS REPORTED THAT DURING INSPECTION ONE UNIT PRESENTED LIQUID INSIDE THE TUBE. THE DEVICE WAS NOT USED ON A PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 7853056 ↗
• MalfunctionSep 6, 2018Obstruction of Flow

  IT WAS REPORTED THAT DURING THE INTERNAL INSPECTION, ONE DEVICE UNIT WAS WITH AN UNIDENTIFIED COLORLESS MATERIAL BLOCKING THE INFUSION TUBE. THE DEVICE WAS NOT USED ON PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7852958 ↗
• MalfunctionSep 6, 2018Obstruction of Flow

  IT WAS REPORTED THAT DURING THE INTERNAL INSPECTION, TWO DEVICE UNITS HAD UNIDENTIFIED COLORLESS MATERIALS BLOCKING THE INFUSION TUBES. THE DEVICES WERE NOT USED ON A PATIENT. THIS REPORT ADDRESSES THE FIRST DEVICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7852957 ↗
• MalfunctionSep 6, 2018Obstruction of Flow

  IT WAS REPORTED THAT DURING THE INTERNAL INSPECTION, TWO DEVICE UNITS HAD UNIDENTIFIED COLORLESS MATERIALS BLOCKING THE INFUSION TUBES. THE DEVICES WERE NOT USED ON A PATIENT. THIS REPORT ADDRESSES THE SECOND DEVICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7852956 ↗
• MalfunctionSep 6, 2018Migration or Expulsion of Device

  IT WAS REPORTED THAT DURING HANDLING IT WAS OBSERVED SALINE LEAKAGE AT CANNULA CONNECTION. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Information

  MAUDE report 7852946 ↗
• MalfunctionSep 6, 2018Contamination

  IT WAS REPORTED THAT DURING INSPECTION ONE UNIT PRESENTED LIQUID INSIDE THE TUBE. IT WAS NOT USED ON A PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7852942 ↗