BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 30ML LL BNS

    MDR report key: 11290169 · Received February 5, 2021

    Report

    Report Number
    1911916-2021-00097
    Event Type
    Malfunction
    Date Received
    February 5, 2021
    Date of Event
    January 7, 2021
    Report Date
    February 12, 2021
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY : A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 301033 AND LOT NUMBER 0115978. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS REPORTED DEFECT. TO AID IN THE INVESTIGATION, THREE PHOTOS WERE PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. THE PHOTOS SHOW TWO SYRINGES. ONE OF THE SYRINGES HAS THE SCALE MARKING ISSUE, BUT THE GRADUATION OF THE SCALE IS LEGIBLE AND ACCEPTABLE. IT COULD BE POSSIBLE FOR THIS DEFECT TO OCCUR IF THE DR. BLADE IS NOT PERFECTLY FLAT. BASED ON THE INVESTIGATION WITH THE PHOTO SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 9 SYRINGE 30ML LL BNS EXPERIENCED SCALE MARKING ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 301033 & BATCH NO: 0115978 . WE HAVE DETECTED A NON-CONFORMANCE WITH LOT # 0115978. THE SPECIFIC FINDING IS RECORDED AS: ON (B)(6) 2021, IN INCOMING INSPECTION IT WAS FOUND THAT NON-STERILE 30CC SYRINGES EXPERIENCED SMUDGED PRINTING. 9 OUT OF THE 20 SYRINGES INSPECTED, EXPERIENCED THIS INCORRECT PRINTING.

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER PHONE #: (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 9 SYRINGE 30ML LL BNS EXPERIENCED SCALE MARKING ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 301033, BATCH NO: 0115978. WE HAVE DETECTED A NON-CONFORMANCE WITH LOT # (B)(4). THE SPECIFIC FINDING IS RECORDED AS: ON (B)(6) 2021, IN INCOMING INSPECTION IT WAS FOUND THAT NON-STERILE 30CC SYRINGES EXPERIENCED SMUDGED PRINTING. 9 OUT OF THE 20 SYRINGES INSPECTED, EXPERIENCED THIS INCORRECT PRINTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184708 SYRINGE 30ML LL BNS PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 0115978

    Patients

    Seq Age Sex Outcome Treatment
    1