BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    10 ML BD POSIFLUSH NORMAL SALINE SYRINGE

    MDR report key: 11325281 · Received February 12, 2021

    Report

    Report Number
    1911916-2021-00121
    Event Type
    Malfunction
    Date Received
    February 12, 2021
    Date of Event
    January 20, 2021
    Report Date
    February 15, 2021
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    NGT
    UDI-DI
    00382903065479
    PMA / PMN Number
    K161552
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 306547 AND LOT NUMBER 0213143. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 3 10 ML BD POSIFLUSH¿ NORMAL SALINE SYRINGES EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 306547. BATCH NO.: 0213143. WE ARE HAVING AN ISSUE WITH SOME OF THE 10ML FLUSHES. AFTER INJECTING THE SALINE, WHEN THEY PULL BACK THE PLUNGER THE BLACK TIP LOOSENS AND THEY GET SOLUTION SQUIRTING OUT THE BACK OF THE SYRINGE. THEIR CONCERN IS THAT THERE COULD BE BLOOD IN THIS CAUSING A POTENTIAL EXPOSURE. THE LOT NUMBER FOR THE LAST INCIDENT IS 0213143.

    Additional Manufacturer Narrative · 1

    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 3 10 ML BD POSIFLUSH¿ NORMAL SALINE SYRINGES EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 306547, BATCH NO.: 0213143. WE ARE HAVING AN ISSUE WITH SOME OF THE 10ML FLUSHES. AFTER INJECTING THE SALINE, WHEN THEY PULL BACK THE PLUNGER THE BLACK TIP LOOSENS AND THEY GET SOLUTION SQUIRTING OUT THE BACK OF THE SYRINGE. THEIR CONCERN IS THAT THERE COULD BE BLOOD IN THIS CAUSING A POTENTIAL EXPOSURE. THE LOT NUMBER FOR THE LAST INCIDENT IS (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221605 10 ML BD POSIFLUSH NORMAL SALINE SYRINGE SALINE, VASCULAR ACCESS FLUSH NGT BD MEDICAL (BD WEST) MEDICAL SURGICAL 0213143 00382903065479

    Patients

    Seq Age Sex Outcome Treatment
    1