BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET

    MDR report key: 19056999 · Received April 7, 2024

    Report

    Report Number
    9617032-2024-00520
    Event Type
    Malfunction
    Date Received
    April 7, 2024
    Date of Event
    March 8, 2024
    Report Date
    April 17, 2024
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    FPA
    UDI-DI
    00382903673445
    PMA / PMN Number
    K220212
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D9: DEVICE AVAILABLE FOR EVALUATION: YES. D.9:DEVICE EVAL BY MANUFACTURER? YES. D9: RETURNED TO MANUFACTURER ON: 2024-APRIL- 15TH. H.6 INVESTIGATION SUMMARY MATERIAL #: 367344. LOT/BATCH #: 3173409. BD RECEIVED 2 SAMPLES FOR INVESTIGATION. THE SAMPLES WERE EVALUATED BY VISUAL EXAMINATION AND THE INDICATED FAILURE MODE FOR CRACKED LUER ADAPTER WITH THE INCIDENT LOT WAS OBSERVED. ADDITIONALLY, 10 RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED BY VISUAL EXAMINATION AND THE ISSUE OF CRACKED LUER ADAPTER 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 CRACKED LUER ADAPTER. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED.

    Additional Manufacturer Narrative · 0

    D2A. COMMON DEVICE NAME: BLOOD SPECIMEN COLLECTION DEVICE; INTRAVASCULAR ADMINISTRATION SET D2B. MEDICAL DEVICE TYPE: JKA H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET, THE LUER CONE IS CRACKED, AND THERE IS A SMALL DRIP WHEN DRAWING BLOOD. THIS OCCURRED IN TEN (10) DEVICES. NO PATIENT IMPACT REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET, THE LUER CONE IS CRACKED, AND THERE IS A SMALL DRIP WHEN DRAWING BLOOD. THIS OCCURRED IN TEN (10) DEVICES. NO PATIENT IMPACT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1084254 BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET SEE H.10 FPA BECTON, DICKINSON AND COMPANY (BD) 3173409 00382903673445

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown