BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 10ML REG PR SALINE 10ML FILL

    MDR report key: 10625570 · Received October 5, 2020

    Report

    Report Number
    1911916-2020-00926
    Event Type
    Malfunction
    Date Received
    October 5, 2020
    Date of Event
    August 6, 2020
    Report Date
    October 5, 2020
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    NGT
    UDI-DI
    00382903065462
    PMA / PMN Number
    K161552
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED LOT NUMBERS 0114381 AND 0021634. 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 SYRINGE 10ML REG PR SALINE 10ML FILL EXPERIENCED DIFFICULT PLUNGER MOVEMENT DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I HAVE RECEIVED THE FOLLOWING PRODUCT COMPLAINT FOR ITEM NUMBER (B)(4): 9 SODIUM CHLORIDE FLUSHES - NOT FLUSHING SEVERAL SODIUM CHLORIDE FLUSHES NOT FLUSHING PROPERLY. SYRINGE DOES NOT MOVE FORWARD WHEN YOU PUSH ON IT AND THEREFORE YOU ARE NOT ABLE TO FLUSH. THIS WAS NOT AN ISOLATED INCIDENT, THIS REPORT IS JUST ONE EXAMPLE LOT NUMBERS FOUND WITH DEFECTIVE FLUSHES SO FAR: LOT #0114381 (X2 FLUSHES) LOT #0021634.

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 0114381, MEDICAL DEVICE EXPIRATION DATE: 2023-04-30, DEVICE MANUFACTURE DATE: 2020-04-23, MEDICAL DEVICE LOT #: 0021634, MEDICAL DEVICE EXPIRATION DATE: 2023-01-31, DEVICE MANUFACTURE DATE: 2020-01-21. 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 SYRINGE 10ML REG PR SALINE 10ML FILL EXPERIENCED DIFFICULT PLUNGER MOVEMENT DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I HAVE RECEIVED THE FOLLOWING PRODUCT COMPLAINT FOR ITEM NUMBER 30654678: 9 SODIUM CHLORIDE FLUSHES, NOT FLUSHING SEVERAL SODIUM CHLORIDE FLUSHES NOT FLUSHING PROPERLY. SYRINGE DOES NOT MOVE FORWARD WHEN YOU PUSH ON IT AND THEREFORE YOU ARE NOT ABLE TO FLUSH. THIS WAS NOT AN ISOLATED INCIDENT, THIS REPORT IS JUST ONE EXAMPLE LOT NUMBERS FOUND WITH DEFECTIVE FLUSHES SO FAR: LOT #0114381 (X2 FLUSHES). LOT #0021634.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1089675 SYRINGE 10ML REG PR SALINE 10ML FILL PREFILLED SALINE SYRINGE NGT BD MEDICAL (BD WEST) MEDICAL SURGICAL SEE H10 00382903065462

    Patients

    Seq Age Sex Outcome Treatment
    1 Other