BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 50CC LL TIP CONVENIENCE PAK

    MDR report key: 11382576 · Received February 25, 2021

    Report

    Report Number
    9610847-2021-00085
    Event Type
    Malfunction
    Date Received
    February 25, 2021
    Date of Event
    January 29, 2021
    Report Date
    March 4, 2021
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    UDI-DI
    00382903096800
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER: 309680 AND LOT NUMBER: 0210120. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. AS A SAMPLE WAS UNAVAILABLE FOR RETURN, A THOROUGH SAMPLE INVESTIGATION COULD NOT BE COMPLETED. BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE FOR THIS INCIDENT COULD NOT BE IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE 50CC LL TIP CONVENIENCE PAK LEAKED. THIS OCCURRED ON 15 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 309680, BATCH NO: 0210120. IT WAS REPORTED THAT THE RUBBER SEAL IS LEAKING.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SYRINGE 50CC LL TIP CONVENIENCE PAK LEAKED. THIS OCCURRED ON 15 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 309680, BATCH NO: 0210120. IT WAS REPORTED THAT THE RUBBER SEAL IS LEAKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279036 SYRINGE 50CC LL TIP CONVENIENCE PAK PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 0210120 00382903096800

    Patients

    Seq Age Sex Outcome Treatment
    1