BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE 18X1-1/2 BLUNT FILL

    MDR report key: 19971507 · Received August 13, 2024

    Report

    Report Number
    1911916-2024-00587
    Event Type
    Malfunction
    Date Received
    August 13, 2024
    Date of Event
    August 6, 2024
    Report Date
    August 29, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    GAA
    UDI-DI
    30382903051800
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL MDR SUBMISSION. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED. THE ACTUAL DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER WAS ENTERED INTO THE DATE OF EVENT FIELD.

    Additional Manufacturer Narrative · 0

    (B)(4) FOLLOW UP FOR DEVICE EVALUATION: IT WAS REPORTED THERE IS EXCESSIVE RESIDUE OF GLUE ON THE HUB. TO AID IN THE INVESTIGATION, EIGHT SAMPLES WITH NO PACKAGING BLISTERS AND ONE PHOTO WAS PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. A VISUAL INSPECTION WAS PERFORMED, AND NO DEFECTS OR IMPERFECTIONS WERE OBSERVED. THE PHOTO PROVIDED SHOWS THE SAMPLES RECEIVED. THE EPOXY IS NORMAL AND JOINS THE NEEDLE TO THE NEEDLE HUB. THE EPOXY ON THE NEEDLES MEETS PRODUCT SPECIFICATIONS. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 305180, LOT 4082873. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL PROCESSES AND FINAL INSPECTIONS COMPLIED WITH SPECIFICATION REQUIREMENTS. TO DATE, THERE HAVE BEEN NO OTHER SIMILAR EVENTS REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION AND WITH THE RETURNED SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED.

    Description of Event or Problem · 0

    MATERIAL # 305180 BATCH # 4082873 IT WAS REPORTED BY CUSTOMER THAT PRODUCT HAS EXCESSIVE RESIDUE OF GLUE ON THE HUB VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. PRODUCT HAS EXCESSIVE RESIDUE OF GLUE ON THE HUB REJECTION# R075024 BUSSE ITEM# 1593A BD ITEM# 305180- 18 GAUGE X 1.5" BLUNT NEEDLE LOT# 4082873 PO 90587 QTY REJECTED 13 CASES (B)(4) PCS.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED. MATERIAL # 305180; BATCH # 4082873. IT WAS REPORTED BY CUSTOMER THAT PRODUCT HAS EXCESSIVE RESIDUE OF GLUE ON THE HUB. RCC RECEIVED A COMPLAINT VIA EMAIL. PRODUCT HAS EXCESSIVE RESIDUE OF GLUE ON THE HUB REJECTION# (B)(4). BUSSE ITEM# 1593A. BD ITEM# 305180- 18 GAUGE X 1.5" BLUNT NEEDLE. LOT# 4082873. PO (B)(4). QTY REJECTED (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2514211 NEEDLE 18X1-1/2 BLUNT FILL NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE GAA BECTON DICKINSON 4082873 30382903051800

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown