BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ SYRINGES

    MDR report key: 16883450 · Received May 6, 2023

    Report

    Report Number
    3003152976-2023-00166
    Event Type
    Malfunction
    Date Received
    May 6, 2023
    Date of Event
    April 14, 2023
    Report Date
    June 7, 2023
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    UDI-DI
    00382903008650
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B.3. DATE OF EVENT IS UNKNOWN; AWARENESS DATE HAS BEEN USED FOR THIS FIELD. H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL: YES. D10: RETURNED TO MANUFACTURER ON: 02-JUN-2023. H6: INVESTIGATION SUMMARY: SAMPLES RECEIVED BY OUR QUALITY TEAM FOR INVESTIGATION. UPON VISUAL EVALUATION, DAMAGED BARREL IS OBSERVED WHICH LIKELY CAUSED THE LEAKAGE. A DEVICE HISTORY REVIEW WAS PERFORMED FOR REPORTED LOT 2211036, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS REPORTED ISSUE. BASED ON THE TEAMS INVESTIGATION, POSSIBLE ROOT CAUSE IS ASSOCIATED WITH MISALIGNMENT IN THE ASSEMBLY MACHINE. FINAL PRODUCTS IN THIS MANUFACTURING LINE, FOR THIS REFERENCE ARE SAMPLED AND THEY ARE SUBJECTED TO VISUAL AND FUNCTIONAL INSPECTIONS DURING THE DIFFERENT MANUFACTURING SUB-PROCESSES ACCORDING TO PROCEDURES. A PROJECT WAS INITIATED TO ADDRESS THIS ISSUE ON OUR PRODUCTS.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD PLASTIPAK¿ SYRINGES THE DEVICE WAS DAMAGED AND LEAKAGE OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: WE HAD A RETURN FROM A DEPARTMENT OF A DEFECTIVE MEDICAL DEVICE. COULD YOU PLEASE SEND US A SECURE BOX TO SEND BACK TO THE MATERIALOVIGILANCE DEPARTMENT? THIS IS A PROBLEM WITH BD PLASTIPAK 60ML SYRINGES REF 300865 LOT NUMBER 2211036: THE SYRINGE LEAKS AT THE PLUNGER WHEN USED. AFTER VISUAL INSPECTION, THE BODY OF THE SYRINGE APPEARS DAMAGED. RECURRING PROBLEM ON SEVERAL SYRINGES OF THE SAME LOT (4 SYRINGES IDENTIFIED; ONE OF WHICH IS IN ITS INTACT PACKAGING).

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD PLASTIPAK¿ SYRINGES THE DEVICE WAS DAMAGED AND LEAKAGE OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: WE HAD A RETURN FROM A DEPARTMENT OF A DEFECTIVE MEDICAL DEVICE. COULD YOU PLEASE SEND US A SECURE BOX TO SEND BACK TO THE MATERIALOVIGILANCE DEPARTMENT? THIS IS A PROBLEM WITH BD PLASTIPAK 60ML SYRINGES REF 300865 LOT NUMBER 2211036: THE SYRINGE LEAKS AT THE PLUNGER WHEN USED. AFTER VISUAL INSPECTION, THE BODY OF THE SYRINGE APPEARS DAMAGED. RECURRING PROBLEM ON SEVERAL SYRINGES OF THE SAME LOT (4 SYRINGES IDENTIFIED; ONE OF WHICH IS IN ITS INTACT PACKAGING).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    467846 BD PLASTIPAK¿ SYRINGES PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2211036 00382903008650

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown