BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYR 10ML SURESCRUB POSIFLUSH SALINE

    MDR report key: 8545226 · Received April 24, 2019

    Report

    Report Number
    1911916-2019-00407
    Event Type
    Malfunction
    Date Received
    April 24, 2019
    Date of Event
    April 8, 2019
    Report Date
    April 10, 2019
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    NGT
    UDI-DI
    30382903065593
    PMA / PMN Number
    K161552
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. MEDICAL DEVICE TYPE: NGT, LKB. PMA/510(K)#: K161552, K121655. INVESTIGATION SUMMARY: THREE SAMPLES WERE RECEIVED. THEY CAME IN TWO PLASTIC BAGS. TWO OF THEM HAVE NO PACKAGING FLOW WRAP, NO TIP CAP AND NO SALINE SOLUTION. THEY HAVE THE PLUNGER ATTACHED TO THE STOPPER. THEY ARE PROPERLY ASSEMBLED AND THERE IS NO GAP BETWEEN THEM. THEY WERE REMOVED FROM BARREL FINDING NO DEFECTS. THE OTHER SYRINGE CAME IN AN OPEN PACKAGING FLOW WRAP. IT HAS SALINE SOLUTION, TIP CAP AND THE PLUNGER ROD- RUBBER STOPPER. AGAIN, THERE IS NO SEPARATION BETWEEN THE PLUNGER ROD AND THE RUBBER STOPPER. THEY WERE REMOVED FROM THE BARREL FINDING NO DEFECTS OR ANY OTHER ISSUE. FAILURE MODE COULD NOT BE VERIFIED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. 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: THIS IS THE 1ST COMPLAINT FOR LOT # 8261704 FOR THIS TYPE OF DEFECT OR SYMPTOM. THERE WAS NO DOCUMENTATION FOR THIS TYPE OF DEFECT DURING THE ENTIRE PRODUCTION RUN OF THIS BATCH. ROOT CAUSE DESCRIPTION: UNDETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOUR SYR 10ML SURESCRUB POSIFLUSH SALINE EXPERIENCED LOOSE PLUNGERS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 306559, LOT NO: 8261704. PER PHONE CALL: NURSE REPORTED THAT WHEN PULLING BACK TO DRAW BLOOD FROM PORT PLUNGER CAME APART FROM THE SYRINGE. NURSE STATED SHE HAD IT HAPPEN 4 TIMES WITHIN THE LAST WEEK. PER CUSTOMER EMAIL RX FROM USER FACILITY, CALLED IN TO REPORT DEFECTIVE POSIFLUSH SYRINGES. THE PLUNGERS ARE FALLING APART AND ARE WOBBLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    336180 SYR 10ML SURESCRUB POSIFLUSH SALINE SALINE, VASCULAR ACCESS FLUSH; PAD, ALCOHOL, DEVICE DISINFECTANT NGT BD MEDICAL (BD WEST) MEDICAL SURGICAL 8261704 30382903065593

    Patients

    Seq Age Sex Outcome Treatment
    1 Other