BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    10 ML BD POSIFLUSH NORMAL SALINE SYRINGE

    MDR report key: 10480712 · Received September 1, 2020

    Report

    Report Number
    1911916-2020-00839
    Event Type
    Malfunction
    Date Received
    September 1, 2020
    Date of Event
    August 4, 2020
    Report Date
    August 20, 2020
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    NGT
    UDI-DI
    30382903065470
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE LOT #: AN INVALID LOT # OF 0042292 WAS PROVIDED. DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. (B)(4). INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR PROVIDED LOT NUMBER 0042292. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS REPORTED INCIDENT. TO AID IN THE INVESTIGATION OF THIS INCIDENT, 16 PHYSICAL SAMPLES WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. THROUGH EXAMINATION OF THE RETURNED SAMPLES, ALL THE DEVICES WERE CONTAMINATED WITH BLOOD. IT WAS EVALUATED THAT BLOOD WAS BETWEEN THE RUBBER STOPPER RIBS, HOWEVER BLOOD WAS NOT OBSERVED PAST THE STOPPER. THIS TYPE OF DEFECT COULD RESULT IF THE PLUNGER ROD WAS PULLED BACK, AS THE SYRINGE IS DESIGNED TO PUSH THE PLUNGER ROD DOWN TO EXPEL SALINE SOLUTION. BASED ON THE INVESTIGATION RESULTS, AN EXACT MANUFACTURING DEFECT FOR THIS INCIDENT COULD NOT BE IDENTIFIED. INVESTIGATION CONCLUSION: THIS TYPE OF DEFECT COULD RESULT IF THE PLUNGER ROD WAS PULLED BACK, AS THE SYRINGE IS DESIGNED TO PUSH THE PLUNGER ROD DOWN TO EXPEL SALINE SOLUTION. BASED ON THE INVESTIGATION RESULTS, AN EXACT MANUFACTURING DEFECT FOR THIS INCIDENT COULD NOT BE IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 6 10 ML BD POSIFLUSH¿ NORMAL SALINE SYRINGES EXPERIENCED LEAKAGE PAST THE STOPPER DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: EVENT DESCRIPTION: I HAVE TWO ADDITIONAL PRODUCT ISSUES REPORTED ON THE PREFILLED SALINE SYRINGES: DATE OF EVENT: 8/4. MANUFACTURE NUMBER: 306547, LOT NUMBER IDENTIFIED: 0042292. ISSUE IDENTIFIED: BLOOD LEAKED OUT THE BACK OF THE PLUNGER WHILE FLUSHING AV FISTULA, PRODUCT WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    944954 10 ML BD POSIFLUSH NORMAL SALINE SYRINGE SALINE, VASCULAR ACCESS FLUSH NGT BD MEDICAL (BD WEST) MEDICAL SURGICAL 306547 SEE H10 30382903065470

    Patients

    Seq Age Sex Outcome Treatment
    1 Other