BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD POSIFLUSH¿ NORMAL SALINE SYRINGE

    MDR report key: 15459048 · Received September 20, 2022

    Report

    Report Number
    1911916-2022-00510
    Event Type
    Malfunction
    Date Received
    September 20, 2022
    Date of Event
    August 24, 2022
    Report Date
    September 27, 2022
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    NGT
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 20-SEP-2022. H6: INVESTIGATION SUMMARY : IT WAS REPORTED THE PRODUCT WAS DAMAGED WHEN IT WAS RECEIVED BY THE CUSTOMER. TO AID IN THE INVESTIGATION, TEN EMPTY SAMPLES WITH NO TIP CAP, OR PACKAGING BLISTERS, WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. A VISUAL INSPECTION WAS PERFORMED AND THE SYRINGE IS DAMAGED. NO OTHER DEFECTS OR IMPERFECTIONS WERE OBSERVED. THIS DEFECT COULD OCCUR IF THERE WAS A JAM DURING THE PLUNGER ROD ASSEMBLY PROCESS INDUCING THE SYMPTOM. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 306594, LOT NUMBER 1140608. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. VERIFICATION OF THE PLUNGER ROD ASSEMBLY PROCESS WAS PERFORMED THE SETTINGS WERE CORRECT AND THE FLOW OF PRODUCT WAS GOOD. BASED ON THE INVESTIGATION AND WITH THE RETURNED SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED. H3 OTHER TEXT : SEE H10.

    Additional Manufacturer Narrative · 0

    INITIAL REPORTER PHONE #: (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 7 BD POSIFLUSH¿ NORMAL SALINE SYRINGES EXPERIENCED DAMAGED PRE-FILLED SYRINGE FLANGES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE PRODUCT WAS DAMAGED AND BROKEN WHEN THE PACKAGE WAS OPENED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 7 BD POSIFLUSH¿ NORMAL SALINE SYRINGES EXPERIENCED DAMAGED PRE-FILLED SYRINGE FLANGES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE PRODUCT WAS DAMAGED AND BROKEN WHEN THE PACKAGE WAS OPENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2661239 BD POSIFLUSH¿ NORMAL SALINE SYRINGE SALINE, VASCULAR ACCESS FLUSH NGT BD MEDICAL (BD WEST) MEDICAL SURGICAL 1140608

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown