BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD POSIFLUSH¿ NORMAL SALINE SYRINGE

    MDR report key: 17438544 · Received August 1, 2023

    Report

    Report Number
    3002682307-2023-00222
    Event Type
    Malfunction
    Date Received
    August 1, 2023
    Date of Event
    July 11, 2023
    Report Date
    September 14, 2023
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    NGT
    UDI-DI
    00382903065752
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IC
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B.3. DATE OF EVENT IS UNKNOWN; AWARENESS DATE HAS BEEN USED FOR THIS FIELD. D.4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. H.4. DEVICE MANUFACTURE DATE: UNKNOWN. H3. 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

    H6. INVESTIGATION SUMMARY: TO AID IN THE INVESTIGATION OF THIS ISSUE, TWO (2) PICTURES WERE PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. THROUGH EXAMINATION OF THE PICTURES, A SYRINGE WITH NO TIP/TIP BREAKAGE WAS OBSERVED. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 306575 AND LOT NUMBER 3052159. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION; THEREFORE, AN EXACT MANUFACTURING RELATED CAUSE COULD NOT BE DETERMINED. THE PICTURE SAMPLES DISPLAY A SYRINGE WITH NO TIP AND A CLEAN BREAK. THIS TYPE OF BREAKAGE IS NOT PRODUCED WITHIN THE MANUFACTURING PROCESS. PER THE PROVIDED FEEDBACK, THE SYRINGE WAS USED WITHOUT ISSUE AND THE TIP BROKE AFTER 3-WAY VALVE DISCONNECTION. THE BD POSIFLUSH ¿ SP SYRINGE IS DESIGNED FOR USE WITH ISO LUER COMPLAINT COMPONENTS FOR INTRAVENOUS APPLICATIONS. ONCE USED, DISCONNECT THE SYRINGE BY UNSCREWING COMPLETELY. NEVER PULL OR BEND AS THAT MAY RESULT IN TIP BREAKAGE. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD POSIFLUSH¿ NORMAL SALINE SYRINGE THE TIP BROKE OFF. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE AT X-RAY HAVE EXPERIENCED WITH SEVERAL POSIFLUSH SYRINGES THAT THE FRONT END THAT CONNECTS TO THE 3 WAY CRANE HAS BROKEN OFF WHEN THEY ARE RELEASED AFTER CONTRAST HAVE BEEN INJECTED. DATE OF INCIDENT: NOT KNOWN. WHEN DID THE INCIDENT OCCUR AFTER USE. HAS THE DEVICE BEEN USED MULTIPLE TIMES OR REUSED? NO.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD POSIFLUSH¿ NORMAL SALINE SYRINGE THE TIP BROKE OFF. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE AT X-RAY HAVE EXPERIENCED WITH SEVERAL POSIFLUSH SYRINGES THAT THE FRONT END THAT CONNECTS TO THE 3 WAY CRANE HAS BROKEN OFF WHEN THEY ARE RELEASED AFTER CONTRAST HAVE BEEN INJECTED. DATE OF INCIDENT: NOT KNOWN. WHEN DID THE INCIDENT OCCUR? AFTER USE. HAS THE DEVICE BEEN USED MULTIPLE TIMES OR REUSED? NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1809613 BD POSIFLUSH¿ NORMAL SALINE SYRINGE SALINE, VASCULAR ACCESS FLUSH NGT BECTON DICKINSON, S.A. 3052159 00382903065752

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown