BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 20ML LL BNS

    MDR report key: 11321673 · Received February 12, 2021

    Report

    Report Number
    1911916-2021-00116
    Event Type
    Malfunction
    Date Received
    February 12, 2021
    Date of Event
    January 14, 2021
    Report Date
    February 4, 2021
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 301031 AND LOT NUMBER 0029383. 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. INVESTIGATION CONCLUSION: COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR QUALITY TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. ROOT CAUSE DESCRIPTION: BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE FOR THIS INCIDENT COULD NOT BE IDENTIFIED. RATIONALE: FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY AT THIS TIME. CAPA NOT REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SYRINGE 20ML LL BNS LABEL HAD THE WRONG INFORMATION FOR THE PRODUCT INSIDE THE BOX. THIS OCCURRED ON 3250 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 301031, BATCH NO.: 0029383. IT WAS REPORTED THAT THE DIAGRAM OF THE PRODUCT ON THE OUTSIDE BOX LABEL SHOWS A LUER LOCK SLIP TIP WHICH DOES NOT MATCH THE LUER LOCK TIP PRODUCT. DESCRIPTION OF NONCONFORMANCE: WHILE PERFORMING THE INCOMING INSPECTION ON THIS BATCH, THE INSPECTOR FOUND THAT THE IMAGE/ DIAGRAM OF THE SYRINGE TIP IS INCORRECT ON THE OUTSIDE LABEL ON THE BOX. THE OUTSIDE LABEL ON THE BOXES HAS AN IMAGE OF A LUER SLIP TIP SYRINGE BUT THIS PRODUCT IS A LUER LOCK TIP SYRINGE. THE VENDOR PART NUMBER AND THE SYRINGE (20ML LUER LOCK) INSIDE ARE CORRECT FOR THIS PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    218604 SYRINGE 20ML LL BNS PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 0029383

    Patients

    Seq Age Sex Outcome Treatment
    1