BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYR 10ML PUMP COMPATIBLE SALINE 10ML FIL

    MDR report key: 11319316 · Received February 11, 2021

    Report

    Report Number
    1911916-2021-00113
    Event Type
    Malfunction
    Date Received
    February 11, 2021
    Date of Event
    January 19, 2021
    Report Date
    February 24, 2021
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    NGT
    UDI-DI
    00382903065479
    PMA / PMN Number
    K161552
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH ADDITIONAL INFORMATION: D.4. MEDICAL DEVICE LOT #: UNKNOWN. D.4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. H.4. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYR 10ML PUMP COMPATIBLE SALINE 10ML FIL LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 306547 BATCH NO: 0213143. IT WAS REPORTED THE BLACK PLUNGER FAILED AND BLOOD SHOT OUT OF THE REAR OF THE SYRINGE ONTO THE NURSE. VERBATIM: HI **** THEY WERE FLUSHING A CENTRAL LINE AND WHEN THEY ASPIRATED THEN WENT TO PUSH BACK THE BLACK PLUNGER FAILED AND BLOOD SHOT OUT OF THE REAR OF THE SYRINGE ONTO THE NURSE. ACCORDING TO THE REPORT THEY HAVE HAD SIMILAR INSTANCES WITH THE LOT IN QUESTION. I HAVE ONE OF THE FAILED FLUSHES AS WELL AS SOME FROM THAT SAME LOT.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. (B)(6). (B)(4). INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 306547 AND LOT NUMBER 0213413. 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, SIX SAMPLES WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. FIVE SAMPLES CAME IN SEALED PACKAGING BLISTERS AND ONE SAMPLE CAME IN A BIOHAZARD PLASTIC BAG. THE USED SAMPLE HAS 2ML OF SOLUTION AND THE RUBBER STOPPER IS AT THE 5.5ML MARK. A VISUAL INSPECTION WAS PERFORMED AND NO DEFECTS OR IMPERFECTIONS WERE OBSERVED. EACH SAMPLE WAS THEN TEST OF LEAKAGE. NO LEAKAGE PAST THE STOPPER WAS SEEN. INVESTIGATION CONCLUSION: COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR QUALITY TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. ROOT CAUSE DESCRIPTION: 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. RATIONALE: FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY AT THIS TIME. CAPA NOT REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SYR 10ML PUMP COMPATIBLE SALINE 10ML FIL LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 306547, BATCH NO: 0213143. IT WAS REPORTED THE BLACK PLUNGER FAILED AND BLOOD SHOT OUT OF THE REAR OF THE SYRINGE ONTO THE NURSE. VERBATIM: "HI, THEY WERE FLUSHING A CENTRAL LINE AND WHEN THEY ASPIRATED THEN WENT TO PUSH BACK THE BLACK PLUNGER FAILED AND BLOOD SHOT OUT OF THE REAR OF THE SYRINGE ONTO THE NURSE. ACCORDING TO THE REPORT THEY HAVE HAD SIMILAR INSTANCES WITH THE LOT IN QUESTION. I HAVE ONE OF THE FAILED FLUSHES AS WELL AS SOME FROM THAT SAME LOT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    215977 SYR 10ML PUMP COMPATIBLE SALINE 10ML FIL SALINE, VASCULAR ACCESS FLUSH NGT BD MEDICAL (BD WEST) MEDICAL SURGICAL UNKNOWN 00382903065479

    Patients

    Seq Age Sex Outcome Treatment
    1