BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD 2 PC 5 ML SYRINGE - DISCARDIT II 24G×1

    MDR report key: 13715830 · Received March 9, 2022

    Report

    Report Number
    2243072-2022-00325
    Event Type
    Malfunction
    Date Received
    March 9, 2022
    Date of Event
    February 24, 2022
    Report Date
    March 23, 2022
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURING LOCATION FOR THIS PRODUCT IS (B)(4). THIS SITE IS AN OEM MANUFACTURING SITE. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: THE VIDEO WAS RECEIVED BY BD FOR EVALUATION. A QUALITY ENGINEER WAS ABLE TO REVIEW THE VIDEO OF A DISCARDIT II 5ML FROM LOT # 1191719 REGARDING ITEM # 300847 WITH THE REPORTED ISSUE OF ¿LEAKAGE¿. THE INVESTIGATING TEAM HAS ALSO USED THE RETENTION SAMPLES FROM LOT # 1191719 REGARDING ITEM # 300847 FOR INVESTIGATING THE REPORTED DEFECT. THE DHR OF LOT # 1191719 ITEM # 300847 WAS CHECKED AND THERE WAS NO QUALITY NOTIFICATION FOUND. THE INVESTIGATION AND SIMULATION WERE CARRIED OUT ON TEN RETENTION SAMPLES WHERE THE INVESTIGATING TEAM HAS VISUALLY TESTED THE SAMPLES AND NO LEAKAGE WAS FOUND. BASED ON THE VIDEO DEFECT IS CONFIRMED. THE VIDEO INDICATES THAT THE NEEDLE IS NOT PROPERLY FIXED WITH THE SYRINGE. THE PROBABLE ROOT CAUSE COULD BE FITMENT OF THE NEEDLE ON THE HUB, THUS INDICATING PRACTICE ISSUE. THE EXACT ROOT CAUSE CAN ONLY BE DETERMINED IF WE RECEIVE THE ORIGINAL SAMPLE. IF SAMPLES ARE RECEIVED IN THE FUTURE THE COMPLAINT WILL BE REOPENED FOR FURTHER INVESTIGATION. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD 2 PC 5 ML SYRINGE - DISCARDIT II 24G×1 LEAKAGE OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SYRINGE / SPINAL NEEDLE LEAKING HAPPENED DURING PROCEDURE WHICH LEAD TO INADEQUATE DOSAGE ADMINISTRATION.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD 2 PC 5 ML SYRINGE - DISCARDIT II 24G×1 LEAKAGE OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SYRINGE / SPINAL NEEDLE LEAKING HAPPENED DURING PROCEDURE WHICH LEAD TO INADEQUATE DOSAGE ADMINISTRATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2659745 BD 2 PC 5 ML SYRINGE - DISCARDIT II 24G×1 PISTON SYRINGE FMF BECTON DICKINSON 1191719

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown