BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD POSIFLUSH NORMAL SALINE SYRINGE

    MDR report key: 10229550 · Received July 3, 2020

    Report

    Report Number
    1911916-2020-00595
    Event Type
    Malfunction
    Date Received
    July 3, 2020
    Date of Event
    May 10, 2020
    Report Date
    June 18, 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 · 1

    (B)(4). INVESTIGATION SUMMARY: SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. HOWEVER, A PROBABLE CAUSE FOR THE DAMAGED BARREL CAN BE INDUCED BY A JAM DURING THE MANUFACTURING PROCESS. INSPECTIONS PERFORMED WHILE PRODUCING THIS LOT WERE ALL GOOD. BASED ON THE INVESTIGATION CARRIED OUT AND WITH NO SAMPLE TO ANALYZE THE SYMPTOM REPORTED BY THE CUSTOMER CAN¿T BE CONFIRMED. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED WITH ZERO DEFECTS FOUND. NO QUALITY NOTIFICATIONS WERE WRITTEN FOR THIS BATCH, NOR FOR THE ASSOCIATED ASSEMBLY BATCHES. INVESTIGATION CONCLUSION: BASED ON NO SAMPLE, THE INVESTIGATION CONCLUDED, BD WAS NOT ABLE TO VERIFY THE INDICATED FAILURE. THIS IS THE 2ND COMPLAINT FOR LOT # 9242395 FOR THIS TYPE OF DEFECT OR SYMPTOM. THIS LOT WAS PRODUCED FOR 1.3824MM UNITS THIS IS A CPM OF 1.4. WE WILL CONTINUE MONITORING THE PERFORMANCE OF THIS LOT. THERE WAS NO DOCUMENTATION FOR THIS TYPE OF DEFECT DURING THE ENTIRE PRODUCTION RUN OF THIS BATCH. ROOT CAUSE DESCRIPTION: BASED ON THE INVESTIGATION CARRIED OUT AND WITH NO SAMPLE TO ANALYZE THE SYMPTOM REPORTED BY THE CUSTOMER CAN¿T BE CONFIRMED NOR COULD THE SYMPTOM BE CORRELATE WITH A ROOT CASE LINKED TO THE MANUFACTURING PROCESS. RATIONALE: CAPA NOT REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD POSIFLUSH¿ NORMAL SALINE SYRINGE BARREL WAS FOUND DAMAGED BEFORE USING IT TO FLUSH THE CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "THE DEEP VEIN CATHETER WAS PLACED IN THE PATIENT'S RIGHT UPPER ARM. WHEN THE RESPONSIBLE NURSE USED THE 10ML PREFILLED CATHETER IRRIGATOR TO FLUSH THE CATHETER FOR INTRAVENOUS INFUSION FOR THE PATIENT, SHE FOUND THAT THE WALL OF THE PREFILLED CATHETER IRRIGATOR WAS DAMAGED AND IMMEDIATELY REPLACED IT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    691925 BD POSIFLUSH NORMAL SALINE SYRINGE SALINE VASCULAR ACCESS FLUSH NGT BD MEDICAL (BD WEST) MEDICAL SURGICAL 9242395

    Patients

    Seq Age Sex Outcome Treatment
    1 Other