BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAF-T-INTIMA W/Y ADAPTER BL 22GA X .75IN

    MDR report key: 10962626 · Received December 7, 2020

    Report

    Report Number
    9610847-2020-00399
    Event Type
    Malfunction
    Date Received
    December 7, 2020
    Date of Event
    November 6, 2020
    Report Date
    February 4, 2021
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FOZ
    UDI-DI
    30382903833239
    PMA / PMN Number
    K013800
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 NUMBER 0030265. 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. FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY AT THIS TIME. SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SAF-T-INTIMA W/Y ADAPTER BL 22GA X .75IN CATHETER WAS SLICED AND LEAKED BLOOD. THIS OCCURRED ON 2 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 383323 BATCH NO: 0030265 IT WAS REPORTED THAT WHEN WITHDRAWING THE SAFETY NEEDLE FROM THE IV THE NEEDLE SLICED THE CATHETER TUBING JUST PROXIMAL TO THE BUTTERFLY. THIS RESULTED IN BLOOD COMING OUT OF THE CATHETER AND ALSO AN UNPROTECTED SHARP STICKING OUT. VERBATIM: INCIDENT WAS REPORTED TO BD REP VIA THE SUPPLY CHAIN SITE LEADER. STILL WAITING ON FURTHER DETAILS, HOWEVER, THE NURSE DESCRIBED "ON (B)(6) 2020 A BD SAF T INTIMA 22 GAUGE IV BUTTERFLY MALFUNCTIONED. WHEN WITHDRAWING THE SAFETY NEEDLE FROM THE IV THE NEEDLE SLICED THE CATHETER TUBING JUST PROXIMAL TO THE BUTTERFLY. THIS RESULTED IN BLOOD COMING OUT OF THE CATHETER AND ALSO AN UNPROTECTED SHARP STICKING OUT. IT DID NOT BUT IT COULD HAVE POTENTIALLY RESULTED IN THE CATHETER PIECE BREAKING OFF AS WELL." THE NURSE MADE MENTION OF THIS HAPPENING A SECOND TIME, I AM TRYING TO GATHER FURTHER DETAILS AS TO WHEN THIS OCCURRED AND WHAT HAPPENED.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SAF-T-INTIMA W/Y ADAPTER BL 22GA X .75IN CATHETER WAS SLICED AND LEAKED BLOOD. THIS OCCURRED ON 2 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 383323, BATCH NO: 0030265. IT WAS REPORTED THAT WHEN WITHDRAWING THE SAFETY NEEDLE FROM THE IV THE NEEDLE SLICED THE CATHETER TUBING JUST PROXIMAL TO THE BUTTERFLY. THIS RESULTED IN BLOOD COMING OUT OF THE CATHETER AND ALSO AN UNPROTECTED SHARP STICKING OUT. VERBATIM: INCIDENT WAS REPORTED TO BD REP VIA THE SUPPLY CHAIN SITE LEADER. STILL WAITING ON FURTHER DETAILS, HOWEVER, THE NURSE DESCRIBED "ON 11/6/20 A BD SAF T INTIMA 22 GAUGE IV BUTTERFLY MALFUNCTIONED. WHEN WITHDRAWING THE SAFETY NEEDLE FROM THE IV THE NEEDLE SLICED THE CATHETER TUBING JUST PROXIMAL TO THE BUTTERFLY. THIS RESULTED IN BLOOD COMING OUT OF THE CATHETER AND ALSO AN UNPROTECTED SHARP STICKING OUT. IT DID NOT BUT IT COULD HAVE POTENTIALLY RESULTED IN THE CATHETER PIECE BREAKING OFF AS WELL." THE NURSE MADE MENTION OF THIS HAPPENING A SECOND TIME, I AM TRYING TO GATHER FURTHER DETAILS AS TO WHEN THIS OCCURRED AND WHAT HAPPENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1427718 SAF-T-INTIMA W/Y ADAPTER BL 22GA X .75IN INTRAVASCULAR CATHETER FOZ BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 383323 0030265 30382903833239

    Patients

    Seq Age Sex Outcome Treatment
    1