BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PRESET¿ ARTERIAL BLOOD COLLECTION SYRINGE

    MDR report key: 18007714 · Received October 25, 2023

    Report

    Report Number
    9617032-2023-01542
    Event Type
    Malfunction
    Date Received
    October 25, 2023
    Date of Event
    September 25, 2023
    Report Date
    November 3, 2023
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    PMA / PMN Number
    K022426
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: MATERIAL #: 364314 LOT/BATCH #: 2091547 BD HAD NOT RECEIVED SAMPLES, BUT 1 PHOTO WAS PROVIDED FOR INVESTIGATION. THE PHOTO WAS REVIEWED AND THE INDICATED FAILURE MODE FOR DEFORMED PLUNGER STOPPER WAS OBSERVED. ADDITIONALLY, 10 RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED BY VISUAL EXAMINATION AND THE ISSUE OF DEFORMED PLUNGER STOPPER WAS NOT OBSERVED. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INCIDENT LOT, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. THERE WERE NO RELATED QUALITY ISSUES DURING MANUFACTURING OF THE PRODUCT. THIS COMPLAINT HAS BEEN CONFIRMED FOR THE INDICATED FAILURE MODE DEFORMED PLUNGER STOPPER. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. H3 OTHER TEXT : SEE H.10

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD PRESET¿ ARTERIAL BLOOD COLLECTION SYRINGE PLUNGER COULD NOT BE PUSHED. NO PATIENT IMPACT WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE NURSE COLLECTS ARTERIAL BLOOD FROM A PATIENT. WHEN SHE OPENED THE ARTERIAL BLOOD COLLECTION NEEDLE FOR INSPECTION, SHE FOUND THAT THERE WAS A PROBLEM WITH THE PLUNGER AND COULD NOT BE PUSHED. SHE IMMEDIATELY STOPPED USING IT AND REPLACED IT WITH A NEW ARTERIAL BLOOD COLLECTION NEEDLE FOR TREATMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD PRESET¿ ARTERIAL BLOOD COLLECTION SYRINGE PLUNGER COULD NOT BE PUSHED. NO PATIENT IMPACT WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE NURSE COLLECTS ARTERIAL BLOOD FROM A PATIENT. WHEN SHE OPENED THE ARTERIAL BLOOD COLLECTION NEEDLE FOR INSPECTION, SHE FOUND THAT THERE WAS A PROBLEM WITH THE PLUNGER AND COULD NOT BE PUSHED. SHE IMMEDIATELY STOPPED USING IT AND REPLACED IT WITH A NEW ARTERIAL BLOOD COLLECTION NEEDLE FOR TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1838936 BD PRESET¿ ARTERIAL BLOOD COLLECTION SYRINGE BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 2091547

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown