BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    10 ML BD POSIFLUSH NORMAL SALINE SYRINGE

    MDR report key: 10411689 · Received August 14, 2020

    Report

    Report Number
    1911916-2020-00749
    Event Type
    Malfunction
    Date Received
    August 14, 2020
    Date of Event
    August 6, 2020
    Report Date
    August 11, 2020
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    NGT
    UDI-DI
    30382903065463
    PMA / PMN Number
    K161552
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. (B)(4). INVESTIGATION SUMMARY: ONE SAMPLE WAS RECEIVED FOR EVALUATION. IT CAME WITH NO PACKAGING FLOW WRAP. NO TIP CAP AND NO SALINE SOLUTION. A FUNCTIONAL TEST WAS PERFORMED BY PULLING THE PLUNGER ROD-RUBBER STOPPER BACK TO THE 10 ML MARK AND TESTING IT TO SUSTAINING FORCE. IT HAD 11.6 N. THE SPECIFICATION IS <20 N. THE SAMPLE RECEIVED IS WITHIN PRODUCT SPECIFICATIONS. ALSO, TWO PHOTOS WERE PROVIDED SHOWING IN EACH PHOTO AN EMPTY SYRINGE WITH NO TIP CAP. ONE OF THE IMAGES SHOWS THE SYRINGE BARREL LABEL. BASED ON THE INVESTIGATION, THE SYMPTOM REPORTED BY THE CUSTOMER COULDN¿T BE CONFIRMED; WE WILL CONTINUE MONITORING AND TRENDING THE COMPLAINTS TO THIS LOT AND SYMPTOM. 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. 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. INVESTIGATION CONCLUSION: THIS IS THE 1ST COMPLAINT FOR LOT # 0042292 FOR THIS TYPE OF DEFECT OR SYMPTOM. THERE WAS NO DOCUMENTATION FOR THIS TYPE OF DEFECT DURING THE ENTIRE PRODUCTION RUN OF THIS BATCH. BASED ON THE INVESTIGATION THE SYMPTOM REPORTED BY THE CUSTOMER COULDN¿T BE CONFIRMED; WE WILL CONTINUE MONITORING AND TRENDING THE COMPLAINTS TO THIS LOT AND SYMPTOM. THIS LOT WAS PRODUCED FOR 1.63 MM UNITS, THIS IS A CPM OF 0.61. ROOT CAUSE DESCRIPTION: THE ROOT CAUSE COULD NOT BE DETERMINED. THE SAMPLE RECEIVED IS WITHIN PRODUCT SPECIFICATIONS. RATIONALE: CAPA NOT REQUIRED AT THIS TIME. A REVIEW OF THE APPLICABLE FMEA/EURA (PEURA(B)(4) INDICATES THAT THE POTENTIAL RISK OF THE REPORTED EVENT WAS ASSESSED APPROPRIATELY IN THE RISK MANAGEMENT DOCUMENTATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF 10 ML BD POSIFLUSH¿ NORMAL SALINE SYRINGES EXPERIENCED DIFFICULT PLUNGER MOVEMENT DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 306546, BATCH NO. 0042292. EVENT DESCRIPTION: SKU: 306546, LOT 0042292, DATE OF OCCURRENCE: UNKNOWN, DATE MADE AWARE: 8/6/20. DESCRIPTION OF EVENT: I GOT A CALL FROM RN FROM ER REGARDING DEFECTIVE SALINE FLUSHES. IT HAS OCCURRED SEVERAL TIMES WITH OTHER NURSES LEADING THEM TO BELIEVE THAT THE PATIENT'S LINES ARE BLOWN. RN EXPLAINED THAT PLUNGER GETS STUCK AND BROUGHT IN A SAMPLE. TO BE HONEST, IT FEELS LIKE THERE IS NEGATIVE PRESSURE IN THE SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    870321 10 ML BD POSIFLUSH NORMAL SALINE SYRINGE SALINE, VASCULAR ACCESS FLUSH NGT BD MEDICAL (BD WEST) MEDICAL SURGICAL 306546 0042292 30382903065463

    Patients

    Seq Age Sex Outcome Treatment
    1 Other