BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 10ML REG PR SALINE 10ML FILL

    MDR report key: 10452131 · Received August 25, 2020

    Report

    Report Number
    1911916-2020-00810
    Event Type
    Malfunction
    Date Received
    August 25, 2020
    Date of Event
    July 23, 2020
    Report Date
    August 27, 2020
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    NGT
    UDI-DI
    30382903065463
    PMA / PMN Number
    K161552
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. NO ROOT CAUSE CAN BE DETERMINED AS NO SAMPLES WERE RECEIVED. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED WITH ZERO DEFECTS FOUND. NO QUALITY NOTIFICATIONS WERE WRITTEN FOR THIS BATCH, NOR FOR THE ASSOCIATED ASSEMBLY BATCHES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE 10ML REG PR SALINE 10ML FILL LEAKED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 306547 BATCH NO.: 0042292 IT WAS REPORTED THAT BLOOD LEAKED OUT BEHIND THE PLUNGER WHILE INFUSING INTO THE VASCULAR ACCESS. PR 3 OF 3: THIS PR IS FOR EVENT ON (B)(6) 2020.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SYRINGE 10ML REG PR SALINE 10ML FILL LEAKED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 306547 BATCH NO.: 0042292. IT WAS REPORTED THAT BLOOD LEAKED OUT BEHIND THE PLUNGER WHILE INFUSING INTO THE VASCULAR ACCESS. PR 3 OF 3: THIS PR IS FOR EVENT ON (B)(6) 2020.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    916658 SYRINGE 10ML REG PR SALINE 10ML FILL SALINE NGT BD MEDICAL (BD WEST) MEDICAL SURGICAL 306546 0042292 30382903065463

    Patients

    Seq Age Sex Outcome Treatment
    1 Other