BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK¿ 10 ML BULK PACK LUER LOCK TIP WITHOUT SAFETY

    MDR report key: 15910332 · Received December 2, 2022

    Report

    Report Number
    1213809-2022-01138
    Event Type
    Malfunction
    Date Received
    December 2, 2022
    Date of Event
    November 9, 2022
    Report Date
    December 22, 2022
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 301029 AND LOT NUMBER 1266636. 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.

    Additional Manufacturer Narrative · 0

    DATE OF EVENT IS UNKNOWN; AWARENESS DATE HAS BEEN USED FOR THIS FIELD. 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 LUER-LOK¿ 10 ML BULK PACK LUER LOCK TIP WITHOUT SAFETY THE PRODUCT WAS DAMAGED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY CUSTOMER THAT " THE SCAR 22-0084 HAS BEEN UPDATED WITH 2 MORE PIECES; LOT 1266636. 1 PIECE WITH A CRACK AND 1 PIECE WITH DAMAGE."

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD LUER-LOK¿ 10 ML BULK PACK LUER LOCK TIP WITHOUT SAFETY, THE PRODUCT WAS DAMAGED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY CUSTOMER THAT " THE SCAR (B)(4) HAS BEEN UPDATED WITH 2 MORE PIECES... LOT 1266636... 1 PIECE WITH A CRACK AND 1 PIECE WITH DAMAGE.".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2083532 BD LUER-LOK¿ 10 ML BULK PACK LUER LOCK TIP WITHOUT SAFETY PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 1266636

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown