BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD POSIFLUSH NORMAL SALINE SYRINGE

    MDR report key: 10646287 · Received October 7, 2020

    Report

    Report Number
    1911916-2020-00940
    Event Type
    Malfunction
    Date Received
    October 7, 2020
    Date of Event
    September 16, 2020
    Report Date
    November 4, 2020
    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

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: 10/27/2020. H.6. INVESTIGATION:A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 306595 AND LOT NUMBER 0072581. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS REPORTED DEFECT. TO AID IN THE INVESTIGATION, TWO PHYSICAL SAMPLES WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. THE SAMPLES CAME WITH NO PACKAGING BLISTER, NO TIP CAP OR SALINE SOLUTION. THEY WERE VISUALLY INSPECTED AND NO DAMAGE OR DEFECTS WERE OBSERVED. EACH WAS THEN TESTED FOR SUSTAINING FORCE AND ALL RESULTS WERE FOUND TO BE WITHIN SPECIFICATION. BASED ON THE INVESTIGATION RESULTS, THE SAMPLES RECEIVED DID NOT SHOW THE SYMPTOM REPORTED BY THE CUSTOMER AND AN EXACT CAUSE FOR THIS INCIDENT COULD NOT BE IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD POSIFLUSH¿ NORMAL SALINE SYRINGE PLUNGER WAS DIFFICULT TO PUSH DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: "THE FLUSH'S PLUNGER ROD CANNOT BE PUSHED HALFWAY DURING USE."

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD POSIFLUSH¿ NORMAL SALINE SYRINGE PLUNGER WAS DIFFICULT TO PUSH DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "THE FLUSH'S PLUNGER ROD CANNOT BE PUSHED HALFWAY DURING USE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1111135 BD POSIFLUSH NORMAL SALINE SYRINGE SALINE VASCULAR ACCESS FLUSH NGT BD MEDICAL (BD WEST) MEDICAL SURGICAL 0072581

    Patients

    Seq Age Sex Outcome Treatment
    1 Other