BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEEDLE INTEGRA 25X1 RB TW

    MDR report key: 19591572 · Received June 23, 2024

    Report

    Report Number
    1213809-2024-00404
    Event Type
    Malfunction
    Date Received
    June 23, 2024
    Date of Event
    May 30, 2024
    Report Date
    July 1, 2024
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    MEG
    UDI-DI
    30382903053118
    PMA / PMN Number
    K011103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    SINCE NO SAMPLES DISPLAYING THE REPORTED CONDITION WERE RECEIVED A POTENTIAL ROOT CAUSE COULD NOT BE DEFINED AND CORRECTIVE ACTIONS ARE NOT NECESSARY. A PHYSICAL SAMPLE IS REQUIRED FOR A MORE THOROUGH EVALUATION AND POTENTIAL ROOT CAUSE DETERMINATION.

    Description of Event or Problem · 0

    MATERIAL# 305311 BATCH# 1172469 IT WAS REPORTED THAT THE BD NEEDLE INTEGRA 25X1 RB TW HAD A NEEDLE RETRACTION FAILURE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: HI, WE HAVE HAD AN ISSUE WITH A 1" RETRACTABLE NEEDLES. THE FIRST IS THAT THE NEEDLE WAS NOT CAPPED WHILE THE PACKAGING WAS STILL SEALED SECOND IS THAT THE NEEDLE DID NOT RETRACT AFTER A VACCINE WAS ADMINISTERED AND THE MA TRIED TO ENGAGE THE SAFETY DATE OCCURRED: THURSDAY ON (B)(6)2024 NO INJURY. BOTH NEEDLE ISSUES WERE FROM THE SAME LOT NUMBER BOTH ARE LOT # 1172469 EXP: 12-31-26 CUSTOMER WOULD LIKE CREDIT FOR 1 BOX.

    Description of Event or Problem · 0

    MATERIAL# 305311. BATCH# 1172469. IT WAS REPORTED BY CUSTOMER THAT THE FIRST IS THAT THE NEEDLE WAS NOT CAPPED WHILE THE PACKAGING WAS STILL SEALED SECOND IS THAT THE NEEDLE DID NOT RETRACT AFTER A VACCINE WAS ADMINISTERED AND THE MA TRIED TO ENGAGE THE SAFETY. VERBATIM: RCC RECEIVED A COMPLAINT VIA PHONE. PIR ATTACHED. HI, WE HAVE HAD AN ISSUE WITH A 1" RETRACTABLE NEEDLES. THE FIRST IS THAT THE NEEDLE WAS NOT CAPPED WHILE THE PACKAGING WAS STILL SEALED SECOND IS THAT THE NEEDLE DID NOT RETRACT AFTER A VACCINE WAS ADMINISTERED AND THE MA TRIED TO ENGAGE THE SAFETY. DATE OCCURRED: THURSDAY (B)(6) 2024. NO INJURY. BOTH NEEDLE ISSUES WERE FROM THE SAME LOT NUMBER BOTH ARE LOT # 1172469 EXP: 12-31-26. CUSTOMER WOULD LIKE CREDIT FOR 1 BOX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1104297 BD NEEDLE INTEGRA 25X1 RB TW SYRINGE, ANTISTICK MEG BECTON DICKINSON MEDICAL SYSTEMS 1172469 30382903053118

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown