BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYR 10ML PUMP COMPATIBLE SALINE 10ML FIL

    MDR report key: 11181485 · Received January 15, 2021

    Report

    Report Number
    1911916-2021-00033
    Event Type
    Malfunction
    Date Received
    January 15, 2021
    Date of Event
    December 23, 2020
    Report Date
    January 6, 2021
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    NGT
    UDI-DI
    30382903065470
    PMA / PMN Number
    K161552
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. (B)(4). INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR PROVIDED LOT NUMBER 231391. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS REPORTED INCIDENT. TO AID IN THE INVESTIGATION OF THIS INCIDENT, 10 SAMPLES WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. A VISUAL INSPECTION WAS PERFORMED AND NO DEFECTS OR IMPERFECTIONS WERE OBSERVED. EACH SAMPLE WAS TESTED FOR SUSTAINING FORCE AND ALL WERE WITHIN SPECIFICATION, HOWEVER, ONE SAMPLE TESTED MEASURED TOWARDS THE HIGHER END OF THE SPECIFICATION LIMIT WHICH COULD HAVE RESULTED IN THE CUSTOMER NOTICING MORE FORCE THAN NORMAL. INVESTIGATION CONCLUSION: BASED ON THE INVESTIGATION AND WITH THE SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED. ROOT CAUSE DESCRIPTION: PROBABLE ROOT CAUSE: ONE SAMPLE MEASURED TOWARDS THE HIGH SPECIFICATION LIMIT, IT COULD BE THAT THE CUSTOMER IS NOTICING MORE FORCE THAN NORMAL IS REQUIRED TO EXPEL THE SOLUTION. RATIONALE: FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY AT THIS TIME. OUR QUALITY TEAM WILL CONTINUE TO MONITOR THE MANUFACTURING PROCESS FOR THIS DEFECT AND OTHER EMERGING TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYR 10ML PUMP COMPATIBLE SALINE 10ML FIL PLUNGER WAS DIFFICULT TO PUSH DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "OUR NURSES USE THE ATTACHED BD SALINE FLUSHES IN PERFORMING APHERESIS ACTIVITIES. IT WAS BROUGHT TO MY ATTENTION YESTERDAY THAT A PARTICULAR LOT OF SYRINGES GAVE INCONSISTENT DELIVERY OF SALINE. SOME SYRINGES BEHAVED NORMALLY; OTHERS IN THE LOT WERE VERY HARD TO PUSH THE PLUNGER. THE NURSES INFORMED ME THAT THEY HAVE NOT EXPERIENCED THIS ISSUE IN THE PAST."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76655 SYR 10ML PUMP COMPATIBLE SALINE 10ML FIL SALINE VASCULAR ACCESS FLUSH NGT BD MEDICAL (BD WEST) MEDICAL SURGICAL 306547 0231391 30382903065470

    Patients

    Seq Age Sex Outcome Treatment
    1