BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    10 ML BD POSIFLUSH NORMAL SALINE SYRINGE

    MDR report key: 10290158 · Received July 17, 2020

    Report

    Report Number
    2243072-2020-01082
    Event Type
    Malfunction
    Date Received
    July 17, 2020
    Date of Event
    July 1, 2020
    Report Date
    July 2, 2020
    Manufacturer
    BECTON DICKINSON
    Product Code
    NGT
    UDI-DI
    30382903065463
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    UNKNOWN MANUFACTURER: THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A CATALOG AND LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. DEVICE EXPIRATION DATE: UNKNOWN. PMA/510(K)#: WITHOUT KNOWING THE MANUFACTURING SITE, THE PMA/510(K)# COULD BE EITHER K161552 OR K141311. DEVICE MANUFACTURE DATE: UNKNOWN. (B)(4). INVESTIGATION SUMMARY: TWO PHOTOS WERE PROVIDED AND EVALUATED. THEY SHOW A SYRINGE IN THE SEALED PACKAGING FLOW WRAP WITH NO SYRINGE BARREL LABEL. THE OTHER PHOTO SHOWS THE SYRINGE WITH NO PACKAGING FLOW WRAP. BASED ON THE INVESTIGATION AND PHOTOS PROVIDED, THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED. A DEVICE HISTORY REVIEW COULD NOT BE COMPLETED AS NO BATCH NUMBER WAS PROVIDED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WOULD 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: LOT # IS UNKNOWN. A DEVICE HISTORY REVIEW COULD NOT BE COMPLETED AS NO BATCH NUMBER WAS PROVIDED. BASED ON THE INVESTIGATION AND PHOTOS PROVIDED THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED. THERE IS A SENSOR THAT IS CHALLENGED AT THE BEGINNING OF THE SHIFT. ROOT CAUSE DESCRIPTION: A POTENTIAL ROOT CAUSE IS ASSOCIATED WITH THE PLUNGER ROD LABELER PROCESS. WHEN THE MACHINE STOPS AND STARTS AGAIN, IT MAY HAVE A MISSING BARREL LABEL AND ESCAPED; THERE ARE NO ADDITIONAL CONTROLS TO DETECT IT. THERE IS A SENSOR THAT IS CHALLENGED AT THE BEGINNING OF THE SHIFT. RATIONALE: CAPA NOT REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE 10 ML BD POSIFLUSH¿ NORMAL SALINE SYRINGE EXPERIENCED MISSING SCALE MARKINGS WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 306546 BATCH NO: UNKNOWN. IT WAS REPORTED THAT SYRINGE WAS MISSING THE SCALE MARKINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    756398 10 ML BD POSIFLUSH NORMAL SALINE SYRINGE PREFILLED SALINE SYRINGE NGT BECTON DICKINSON 306546 UNKNOWN 30382903065463

    Patients

    Seq Age Sex Outcome Treatment
    1 Other