BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAF-T-INTIMA¿ SAFETY SYSTEM WITH Y ADAPTER 22 GA 0.75 IN

    MDR report key: 17446253 · Received August 2, 2023

    Report

    Report Number
    9610847-2023-00209
    Event Type
    Malfunction
    Date Received
    August 2, 2023
    Date of Event
    July 14, 2023
    Report Date
    September 5, 2023
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FOZ
    UDI-DI
    30382903833239
    PMA / PMN Number
    K923702
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: IT WAS REPORTED THE NEEDLE IS PUNCTURING THE SIDE OF THE CATHETER SHEATH WHEN WITHDRAWING THE NEEDLE. AS A SAMPLE WAS NOT RETURNED, A THOROUGH SAMPLE INVESTIGATION COULD NOT BE COMPLETED. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 383323, LOT 1210978. THE REVIEW DID NOT REVEAL ANY QUALITY NOTIFICATIONS RELATED TO COMPLAINT REPORTED. ACCORDING TO SAMPLING PLAN APPLIED FOR PRODUCT PERFORMANCE, THIS LOT WAS ACCEPTED. BASED ON THE INVESTIGATION, BD WAS NOT ABLE TO CONFIRM THE INDICATED FAILURE MODE AS NO DEFECTIVE SAMPLES OR PHOTOS WERE RETURNED.

    Additional Manufacturer Narrative · 0

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH ADDITIONAL LOT NUMBER IS AS FOLLOWS: D4. MEDICAL DEVICE LOT #: 1210978; D4. MEDICAL DEVICE EXPIRATION DATE: 31JUL2025; H4. DEVICE MANUFACTURE DATE: 11AUG2021. 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 WHILE USING BD SAF-T-INTIMA¿ SAFETY SYSTEM WITH Y ADAPTER 22 GA 0.75 IN THE NEEDLE PIERCED THE CATHETER. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ALL FOR SAF-T-INTIMA: NO FLASH IS BEING SEEN WHEN LINE IS INSERTED, NEEDLE IS NOT VISIBLE ABOVE SHEATH, THE NEEDLE IS PUNCTURING THE SIDE OF THE CATHETER SHEATH WHEN WITHDRAWING THE NEEDLE.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD SAF-T-INTIMA¿ SAFETY SYSTEM WITH Y ADAPTER 22 GA 0.75 IN THE NEEDLE PIERCED THE CATHETER. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ALL FOR SAF-T-INTIMA: NO FLASH IS BEING SEEN WHEN LINE IS INSERTED, NEEDLE IS NOT VISIBLE ABOVE SHEATH, THE NEEDLE IS PUNCTURING THE SIDE OF THE CATHETER SHEATH WHEN WITHDRAWING THE NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    796488 BD SAF-T-INTIMA¿ SAFETY SYSTEM WITH Y ADAPTER 22 GA 0.75 IN INTRAVASCULAR CATHETER FOZ BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 2014866 30382903833239

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown