BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD DISCARDIT II 2-PIECE SYRINGE

    MDR report key: 16261160 · Received January 28, 2023

    Report

    Report Number
    3002682307-2023-00006
    Event Type
    Malfunction
    Date Received
    January 28, 2023
    Date of Event
    January 9, 2023
    Report Date
    March 13, 2023
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    UDI-DI
    00382903091102
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D4: MEDICAL DEVICE LOT #: 2210138. D4: MEDICAL DEVICE EXPIRATION DATE: 30-SEP-2027. H4: DEVICE MANUFACTURE DATE: 03-OCT-2022. D4: MEDICAL DEVICE LOT #: 2007232. D4: MEDICAL DEVICE EXPIRATION DATE: 30-JUN-2025. H4: DEVICE MANUFACTURE DATE: 23-JUL-2020. D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 01-FEB-2023. H6: INVESTIGATION SUMMARY A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 309110 AND LOT NUMBER 2210138 AND RETURNED LOT NUMBER 2007232. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. TO AID IN THE INVESTIGATION OF THIS ISSUE, OVER FORTY SYRINGES OF LOT NUMBER 2210138 AND ADDITIONAL SYRINGES BELONGING TO LOT NUMBER 2007232 WERE RETURNED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THROUGH EXAMINATION OF THE SYRINGES BELONGING TO LOT NUMBER 2210138, NO SIGNS OF LEAKAGE WERE OBSERVED. HOWEVER, LEAKAGE COULD BE CONFIRMED WITH THE SAMPLES BELONGING TO LOT NUMBER 2007232. IT HAS BEEN DETERMINED THAT THE LEAKAGE WAS MOST LIKELY DUE TO DAMAGE IN THE PLUNGER LIP COMPONENT. THIS TYPE OF DAMAGE MAY BE PRODUCED DURING THE HANDLING OF THE PRODUCT THROUGH THE MANUFACTURING PROCESS OR WITHIN THE PLUNGER ASSEMBLY MACHINE.

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD DISCARDIT II 2-PIECE SYRINGE LEAKAGE OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FINNISH TO ENGLISH: DESCRIPTION OF THE PRODUCT COMPLAINT: MEDICINE CAN LEAK OUT FROM NEXT TO THE PISTON. THAT IS, IF YOU LIFT THE SYRINGE UP TO GET THE AIR OUT, THE MEDICINE WILL FLOW OUT NEXT TO THE PISTON.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD DISCARDIT II 2-PIECE SYRINGE LEAKAGE OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FINNISH TO ENGLISH: DESCRIPTION OF THE PRODUCT COMPLAINT: MEDICINE CAN LEAK OUT FROM NEXT TO THE PISTON. THAT IS, IF YOU LIFT THE SYRINGE UP TO GET THE AIR OUT, THE MEDICINE WILL FLOW OUT NEXT TO THE PISTON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    846288 BD DISCARDIT II 2-PIECE SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. SEE H10 00382903091102

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown