BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 3ML LL W/NDL 22X3/4 RB

    MDR report key: 8411919 · Received March 12, 2019

    Report

    Report Number
    1213809-2019-00316
    Event Type
    Malfunction
    Date Received
    March 12, 2019
    Date of Event
    February 22, 2019
    Report Date
    April 23, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903095699
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELD WAS UPDATED DUE TO CORRECTED INFORMATION DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT THE SYRINGE 3ML LL W/NDL 22X3/4 RB EXPERIENCED BREAKAGE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE CUSTOMER: VERBATIM: ¿SHE ALSO REPORTED A SECOND LOT # 8329966 WHERE THE NEEDLES ARE BREAKING OFF OF THE HUB DURING THEIR USE. SHE DID NOT KNOW HOW MANY EXACTLY (¿A FEW¿), SAID THAT THEY BEEN ¿HAPPENING ON DIFFERENT DAYS¿ BUT DID NOT KNOW THE DATES. SHE DID SAY THAT SHE WILL ADD 3 SAMPLES FROM THIS LOT INTO THE SHIPMENT FOR (B)(4). INVESTIGATION: SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT, THEREFORE A ROOT CAUSE COULD NOT BE DETERMINED. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SYRINGE 3ML LL W/NDL 22X3/4 RB EXPERIENCED BREAKAGE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE CUSTOMER: VERBATIM: ¿SHE ALSO REPORTED A SECOND LOT # 8329966 WHERE THE NEEDLES ARE BREAKING OFF OF THE HUB DURING THEIR USE. SHE DID NOT KNOW HOW MANY EXACTLY (¿A FEW¿), SAID THAT THEY BEEN ¿HAPPENING ON DIFFERENT DAYS¿ BUT DID NOT KNOW THE DATES. SHE DID SAY THAT SHE WILL ADD 3 SAMPLES FROM THIS LOT INTO THE SHIPMENT FOR (B)(4).

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYRINGE 3ML LL W/NDL 22X3/4 RB EXPERIENCED BREAKAGE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE CUSTOMER: VERBATIM: ¿SHE ALSO REPORTED A SECOND LOT # 8329966 WHERE THE NEEDLES ARE BREAKING OFF OF THE HUB DURING THEIR USE. SHE DID NOT KNOW HOW MANY EXACTLY (¿A FEW¿), SAID THAT THEY BEEN ¿HAPPENING ON DIFFERENT DAYS¿ BUT DID NOT KNOW THE DATES. SHE DID SAY THAT SHE WILL ADD 3 SAMPLES FROM THIS LOT INTO THE SHIPMENT FOR PR 801931.¿ SEE PR FOR ADDITIONAL DETAILS. COMPLAINT SUMMARY DETAIL: THIS IS MDR REPORTABLE. THE INCIDENT COULD HAVE POTENTIAL TO CAUSE HARM/SERIOUS INJURY. THE INCIDENT COULD HAVE POTENTIAL TO IMPACT MEDICATION DELIVERY. EVENT TYPE: BREAKS DURING USE / MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    208286 SYRINGE 3ML LL W/NDL 22X3/4 RB PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 8329966 30382903095699

    Patients

    Seq Age Sex Outcome Treatment
    1 Other