Plastipak 302553Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 07501073025530), received between Sep 26, 2022 and Mar 4, 2025 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Device Markings/Labelling Problem” (7 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 4, 2025Contamination; Contamination

  IT WAS REPORTED THAT THE BD SYRINGE 5ML LL SYRINGE ONLY MX BUN HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER TRANSLATED FROM SPANISH TO ENGLISH: I NOTIFY THE REJECTION OF 300 PIECES OF THE MATERIAL 1012429 5 ML PLASTIPAK S/A LUER LOCK SYRINGE EXPIRATION 30JUN27, LOT 2208043, DUE TO THE PRESENCE OF PARTICLES. DURING THE INSPECTION, 4 PIECES WERE FOUND TO BE DEFECTIVE DUE TO THE PRESENCE OF FOREIGN PARTICLES IN THE CONTENTS. ADDITIONAL INFORMATION PROVIDED: COULD YOU CONFIRM THAT, OF THE 300 PIECES, THE PIECES WERE IDENTIFIED IN THE SAME BOX? THE PIECES THAT PRESENTED THE DEFECT WERE IDENTIFIED IN DIFFERENT BOXES. ARE ADDITIONAL PHOTOS OF THE NEEDLE RELATED TO THE INCIDENT AVAILABLE FOR ANALYSIS? THE INPUT IS AVAILABLE, IF YOU REQUIRE ANY ADDITIONAL PHOTOGRAPHS, THEY CAN BE TAKEN. IS THE SAMPLE RELATED TO THE REPORTED EVENT AVAILABLE FOR ANALYSIS? IF SO, INDICATE THE QUANTITY. 4 PIECES WITH QUALITY DEFECT (300 PIECES TO BE RETURNED). NAME OF SENDER: (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21514186 ↗
• MalfunctionDec 5, 2024Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT THE BD SYRINGE 5ML LL SYRINGE ONLY MX BUN HAD DISCOLORATION / VARIATION IN COLOR / CLOUDY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER TRANSLATED FROM SPANISH TO ENGLISH: SYRINGES WITH PRIMARY PACKAGING WITH YELLOW COLORATION ARE BEING FOUND DURING MANUFACTURING, SO WE ARE NOT SURE THAT THIS MATERIAL IS IN CONDITIONS TO BE USED, BECAUSE OUR CUSTOMERS DO NOT HAVE THE CONFIDENCE TO USE THIS MATERIAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20855718 ↗
• MalfunctionNov 23, 2024Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT THE BD SYRINGE 5ML LL SYRINGE ONLY MX BUN PACKAGING HAD DISCOLORATION / VARIATION IN COLOR / CLOUDY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER TRANSLATED FROM SPANISH TO ENGLISH: SYRINGES WITH PRIMARY PACKAGING WITH YELLOW COLORATION ARE BEING FOUND DURING MANUFACTURING, SO WE ARE NOT SURE THAT THIS MATERIAL IS IN CONDITIONS TO BE USED, BECAUSE OUR CUSTOMERS DO NOT HAVE THE CONFIDENCE TO USE THIS MATERIAL. ADDITIONAL INFORMATION RECEIVED ON 04NOV2024 ¿ THE FOLLOWING DATES OF OCCURRENCE ARE REPORTED IN THE PREVIOUS EMAIL: OCTOBER 23, 25, AND 26. COULD YOU PLEASE HELP US FILL OUT THE TABLE BELOW, INCLUDING THE RESPECTIVE QUANTITIES IDENTIFIED WITH RESPECT TO THE DEFECT FOR EACH OF THE DATES? DATE LOT QUANTITY, PCS OCTOBER 23 - - OCTOBER 25 - - OCTOBER 26 2098020 494 ¿ COULD YOU SHARE PHOTOS FOR BATCH MATERIALS 2098020? PHOTS ADDED IN ATTACHMENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20766963 ↗
• MalfunctionJul 17, 2024Volume Accuracy Problem; Volume Accuracy Problem

  IT WAS REPORTED THAT THE BD SYRINGE 5ML LL SYRINGE ONLY MX BUN HAD A SCALE MARKING ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER TRANSLATED FROM SPANISH TO ENGLISH: DURING THE INSPECTION OF INPUTS, IN THE FUNCTIONAL TEST OF DIVISION OF THE SYRINGE, 2 PCS ARE DETECTED OUT OF VALUES ABOVE THE MILLILITER AND IN THE SUB DIVISION TEST 9 PCS ABOVE 0.2 MM AND 4 BELOW 0.2 MM. OUR TEST IS BY WEIGHT CONSIDERING THE DENSITY OF WATER AS 1G/ML TO VALIDATE THE VOLUME VS. THE DIVISIONS AND SUBDIVISIONS OF THE SYRINGE. THE BALANCE IS CALIBRATED AND THE TOLERANCE IS 4%.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19767668 ↗
• MalfunctionSep 18, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE BD PLASTIPAK¿ SYRINGE HAD MISSING SCALE MARKINGS. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 7 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH: "SYRINGES WITHOUT SCALE OR WITH PARTIALLY ERASED SCALE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17770443 ↗
• MalfunctionSep 18, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE BD PLASTIPAK¿ SYRINGE HAD MISSING SCALE MARKINGS. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 7 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH: "SYRINGES WITHOUT SCALE OR WITH PARTIALLY ERASED SCALE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17770442 ↗
• MalfunctionSep 18, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE BD PLASTIPAK¿ SYRINGE HAD MISSING SCALE MARKINGS. THIS COMPLAINT WAS CREATED TO CAPTURE THE 3RD OF 7 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH: "SYRINGES WITHOUT SCALE OR WITH PARTIALLY ERASED SCALE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17770441 ↗
• MalfunctionSep 18, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem

  ADDITIONAL INFORMATION RECEIVED SYRINGES WITHOUT SCALE OR WITH PARTIALLY ERASED SCALE. CUSTOMER PROVIDED TO US THE ADDITIONAL INFORMATION ON 15.SEP.2023. - THE REPORTED BATCH (2117458) IS UNKNOWN, IT DOES NOT CORRESPOND TO A SYRINGE, COULD YOU KINDLY TELL US WHAT THE BATCH OF THE PRODUCT IS? IS THAT LOT A NEEDLE, WAS THE NEEDLE USED? WHAT WAS THE DETOUR? 2045792. - WAS THE REPORTED INCIDENT NOTICED BEFORE, DURING OR AFTER USE? BEFORE. - HAS THERE BEEN ANY HARM TO THE PATIENT/HEALTHCARE PROFESSIONAL? (DETAIL) NO. - WAS THERE A NEED FOR MEDICAL AND/OR SURGICAL INTERVENTION DUE TO WHAT OCCURRED (IMAGING EXAMINATIONS, SURGERY, MEDICATION ADMINISTRATION, ETC.)? (DETAIL) NO. - HAS THERE BEEN EXPOSURE OF BLOOD OR CHEMOTHERAPY TO THE MUCOUS MEMBRANES OR SKIN? (DETAIL) NO. - DO YOU HAVE PRODUCTS AVAILABLE FOR EVALUATION? ALREADY COLLECTED BY YOU. - COULD YOU SEND PHOTOS OF THE SAMPLE? YES / ALREADY SENT IN THE INCIDENT EMAILS. - COULD YOU SEND THE QUANTITY FOR THIS PRODUCT? 39.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17770440 ↗
• MalfunctionSep 18, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE BD PLASTIPAK¿ SYRINGE HAD MISSING SCALE MARKINGS. THIS COMPLAINT WAS CREATED TO CAPTURE THE 4TH OF 7 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH: "SYRINGES WITHOUT SCALE OR WITH PARTIALLY ERASED SCALE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17770438 ↗
• MalfunctionSep 18, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem

  ADDITIONAL INFORMATION RECEIVED. SYRINGES WITHOUT SCALE OR WITH PARTIALLY ERASED SCALE. CUSTOMER PROVIDED TO US THE ADDITIONAL INFORMATION ON 15.SEP.2023. THE REPORTED BATCH (2117458) IS UNKNOWN, IT DOES NOT CORRESPOND TO A SYRINGE, COULD YOU KINDLY TELL US WHAT THE BATCH OF THE PRODUCT IS? IS THAT LOT A NEEDLE, WAS THE NEEDLE USED? WHAT WAS THE DETOUR? 2045792. WAS THE REPORTED INCIDENT NOTICED BEFORE, DURING OR AFTER USE? BEFORE. HAS THERE BEEN ANY HARM TO THE PATIENT/HEALTHCARE PROFESSIONAL? (DETAIL) NO. WAS THERE A NEED FOR MEDICAL AND/OR SURGICAL INTERVENTION DUE TO WHAT OCCURRED (IMAGING EXAMINATIONS, SURGERY, MEDICATION ADMINISTRATION, ETC.)? (DETAIL) NO. HAS THERE BEEN EXPOSURE OF BLOOD OR CHEMOTHERAPY TO THE MUCOUS MEMBRANES OR SKIN? (DETAIL) NO. DO YOU HAVE PRODUCTS AVAILABLE FOR EVALUATION? ALREADY COLLECTED BY YOU. COULD YOU SEND PHOTOS OF THE SAMPLE? YES / ALREADY SENT IN THE INCIDENT EMAILS. COULD YOU SEND THE QUANTITY FOR THIS PRODUCT? 39.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17768713 ↗
• MalfunctionSep 18, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE BD PLASTIPAK¿ SYRINGE HAD MISSING SCALE MARKINGS. THIS COMPLAINT WAS CREATED TO CAPTURE THE 7TH OF 7 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH: "SYRINGES WITHOUT SCALE OR WITH PARTIALLY ERASED SCALE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17768701 ↗
• MalfunctionSep 28, 2022Inaccurate Information; Inaccurate Information

  IT WAS REPORTED THAT 2 BD PLASTIPAK¿ SYRINGE SCALE MARKING LINES WERE NOT LOCATED AT THE RIGHT ANGLES ON THE BARREL. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH: "GRADUATION LINES MUST BE LOCATED AT RIGHT ANGLES TO THE LONGITUDINAL AXIS OF THE CYLINDER OR BARREL."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15499219 ↗
• MalfunctionSep 26, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT 2 BD PLASTIPAK¿ SYRINGE HAD DIFFICULT PLUNGER MOVEMENT. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH: "CYLINDER MADE OF MEDICAL GRADE MATERIAL, WHICH FITS PERFECTLY INSIDE THE BARREL AND IS EASILY MOVED MANUALLY BOTH INSIDE IT. ALTHOUGH THE PLUNGER MOVES, IT DOES NOT MOVE EASILY. IT MUST BE TAKEN INTO ACCOUNT THAT, FOR A REPETITIVE ACTION, THE USER COULD HAVE PAIN AND/OR INJURY, IN ADDITION TO INCURRING AN ADVERSE EFFECT ON THE USE WITH THE PATIENT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15486856 ↗