BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 1ML S/T W/NDL 25X5/8 RB

    MDR report key: 11060968 · Received December 22, 2020

    Report

    Report Number
    1213809-2020-00912
    Event Type
    Malfunction
    Date Received
    December 22, 2020
    Date of Event
    November 24, 2020
    Report Date
    January 29, 2021
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096269
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: 1/13/2021. H.6. INVESTIGATION: ONE LOOSE 1ML S/T SYRINGE WITH NEEDLE ATTACHED AND A PIECE OF TOP WEB FROM THE PACKAGE WERE RECEIVED. THE SAMPLE WAS VISUALLY EVALUATED. THE TOP WEB CONFIRMED THE BATCH #8061711 (P/N 309626). THE SAMPLE HAD UNIDENTIFIED LIQUID IN THE FLUID PATH AND APPEARED TO HAVE BEEN USED. THEREFORE, THE SAMPLE COULD NOT BE EVALUATED. NO REPRESENTATIVE SAMPLES FROM THE SAME BOX AND/OR LOT WERE RECEIVED FOR EVALUATION. THEREFORE, THE DEFECT COULD NOT BE CONFIRMED. SINCE NO DEFECTS WERE CONFIRMED, CORRECTIVE ACTIONS ARE NOT NECESSARY. 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 SYRINGE 1ML S/T W/NDL 25X5/8 RB SPUN OUT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "MATERIAL NO: 309626 BATCH NO: 8061711. IT WAS REPORTED THAT THE NEEDLE HUB COMES OFF OF THE SYRINGE WHEN THE NEEDLE PROTECTOR PULLED OFF THE SYRINGE. VERBATIM: FROM PHONE CALL ON (B)(6) 2020 13:31:06: CALLED CONSUMER TO OBTAIN PHARMACY INFORMATION FOR PRODUCT REPLACEMENT. CONSUMER STATED EVERY TIME TO SHE GOES TO REMOVE THE ORANGE CAP THE NEEDLE COMES OFF WITH THE CAP. STATED THIS HAPPENED YESTERDAY ALSO. PROVIDED PHARMACY INFORMATION FOR REPLACEMENT. LG EMAIL RECEIVED (B)(6) 2020 08:33:39. PER VERBATIM IN COMPLAINT FORM: " THE HUB COMES OFF OF THE SYRINGE WHEN SHE PULLS THE NEEDLE PROTECTOR OFF THE SYRINGE. THE CUSTOMER WAS A RETIRED NURSE.CUSTOMER HAS HAD THE BOX OF 100 FOR THE LAST YEAR ". LOT # 8061711. CAT # 3096260 DATE OF EVENT: (B)(6) 2020. BD AWARENESS DATE: 11/24/20 SAMPLES: YES"

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SYRINGE 1ML S/T W/NDL 25X5/8 RB SPUN OUT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "MATERIAL NO: 309626, BATCH NO: 8061711. IT WAS REPORTED THAT THE NEEDLE HUB COMES OFF OF THE SYRINGE WHEN THE NEEDLE PROTECTOR PULLED OFF THE SYRINGE. VERBATIM: FROM PHONE CALL ON (B)(6) 2020 13:31:06: CALLED CONSUMER TO OBTAIN PHARMACY INFORMATION FOR PRODUCT REPLACEMENT. CONSUMER STATED EVERY TIME TO SHE GOES TO REMOVE THE ORANGE CAP THE NEEDLE COMES OFF WITH THE CAP. STATED THIS HAPPENED YESTERDAY ALSO. PROVIDED PHARMACY INFORMATION FOR REPLACEMENT. LG. EMAIL RECEIVED (B)(6) 2020 08:33:39 PER VERBATIM IN COMPLAINT FORM: THE HUB COMES OFF OF THE SYRINGE WHEN SHE PULLS THE NEEDLE PROTECTOR OFF THE SYRINGE. THE CUSTOMER WAS A RETIRED NURSE. CUSTOMER HAS HAD THE BOX OF 100 FOR THE LAST YEAR . LOT # 8061711, CAT # 309626, DATE OF EVENT: (B)(6) 2020 BD AWARENESS DATE: (B)(6) 2020 SAMPLES: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1523318 SYRINGE 1ML S/T W/NDL 25X5/8 RB PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 309626 8061711 30382903096269

    Patients

    Seq Age Sex Outcome Treatment
    1