BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYR 10ML PUMP COMPATIBLE SALINE 10ML FIL

    MDR report key: 11219869 · Received January 23, 2021

    Report

    Report Number
    1911916-2021-00043
    Event Type
    Malfunction
    Date Received
    January 23, 2021
    Date of Event
    December 15, 2020
    Report Date
    January 18, 2021
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    UDI-DI
    00382903065479
    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

    MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 0190658, MEDICAL DEVICE EXPIRATION DATE: 2023-06-30, DEVICE MANUFACTURE DATE: (B)(6) 2020. MEDICAL DEVICE LOT #: 0190661, MEDICAL DEVICE EXPIRATION DATE: 2023-06-30, DEVICE MANUFACTURE DATE: (B)(6) 2020. INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER (B)(4) AND LOT NUMBER (B)(4). 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. FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY AT THIS TIME. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 2 SYR 10ML PUMP COMPATIBLE SALINE 10ML FIL LEAKED PAST THE STOPPER DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED -BLOOD LEAKED OUTSIDE OF PLUNGER WHEN INFUSING INTO A DIALYSIS CATHETER. VERBATIM: PER CUSTOMER'S RESPONSE: WAS ANYONE HURT? NO, IT DID HOWEVER LEAVE THE TECH AT RISK FOR BLOOD EXPOSURE. WOULD YOU PLEASE SEND US CORRECT LOT#?THIS IS WHAT WAS REPORTED. DO YOU HAVE PATIENT IDENTIFIERS? THIS IS NOT AVAILABLE. DO YOU HAVE DATE OF EVENT? (B)(6) 2020. PRODUCT-0.9 % SODIUM CHLORIDE INJECTION, MANUFACTURE NUMBER (B)(4), LOT NUMBER 0190658. PRODUCT ISSUE-BLOOD LEAKED OUTSIDE OF PLUNGER WHEN INFUSING INTO A DIALYSIS CATHETER. PRODUCT-0.9% SODIUM CHLORIDE INJECTION, MANUFACTURE NUMBER (B)(4), LOT NUMBER 01900661, PRODUCT ISSUE-WHEN INFUSING AND PULLING BACK ON THE SYRINGE, FROM A DIALYSIS CATHETER/FISTULA, BLOOD SQUIRTS OUT OF THE BACK END OF SYRINGE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116243 SYR 10ML PUMP COMPATIBLE SALINE 10ML FIL PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL SEE H.10. 00382903065479

    Patients

    Seq Age Sex Outcome Treatment
    1