BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEEDLE ECLIPSE 21X1-1/2 RB

    MDR report key: 19932337 · Received August 7, 2024

    Report

    Report Number
    2243072-2024-00869
    Event Type
    Malfunction
    Date Received
    August 7, 2024
    Date of Event
    June 12, 2024
    Report Date
    August 19, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    UDI-DI
    00382903057658
    PMA / PMN Number
    K010188
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON DEVICE HISTORY RECORD REVIEW, NO ABNORMALITY WAS OBSERVED DURING THE PRODUCTION OF THE AFFECTED BATCHES. CURRENT CONTROL THERE IS A VISUAL INSPECTION ON DAMAGED COMPONENT QA OUTGOING INSPECTION PER MQA-052/A AND VISUAL INSPECTION ON DAMAGED COMPONENT AT ASSEMBLY IN-PROCESS INSPECTION PER MFG-043/I. ACTUAL ROOT CAUSE COULD NOT BE DETERMINED AS ACTUAL SAMPLE WAS NOT RECEIVED FOR INVESTIGATION. THE COMPLAINT WILL BE RE-OPENED AND RE-INVESTIGATED WHEN SAMPLE IS RECEIVED.

    Additional Manufacturer Narrative · 0

    BASED ON DEVICE HISTORY RECORD REVIEW, NO ABNORMALITY WAS OBSERVED DURING THE PRODUCTION OF THE AFFECTED BATCHES. CURRENT CONTROL THERE IS A VISUAL INSPECTION ON DAMAGED COMPONENT QA OUTGOING INSPECTION AND VISUAL INSPECTION ON DAMAGED COMPONENT AT ASSEMBLY IN-PROCESS INSPECTION. ACTUAL ROOT CAUSE COULD NOT BE DETERMINED AS ACTUAL SAMPLE WAS NOT RECEIVED FOR INVESTIGATION. THE COMPLAINT WILL BE RE-OPENED AND RE-INVESTIGATED WHEN SAMPLE IS RECEIVED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD NEEDLE ECLIPSE 21X1-1/2 RB NEEDLE BROKE. IT WAS REPORTED BY CUSTOMER THAT THE INCIDENT WITH AN ECLIPSE 21G 1 1/2 LOT NEEDLE 1362829 EXP 2026-12-31 THAT OCCURRED AT OUR CLINIC YESTERDAY DURING THE INJECTION OF A MEDICATION TO ONE OF OUR PATIENTS. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. I WOULD LIKE TO REPORT AN INCIDENT WITH AN ECLIPSE 21G 1 1/2 LOT NEEDLE 1362829 EXP 2026-12-31 THAT OCCURRED AT OUR CLINIC YESTERDAY DURING THE INJECTION OF A MEDICATION TO ONE OF OUR PATIENTS. UNFORTUNATELY, THE DEFECTIVE NEEDLE WAS THROWN INTO THE NEEDLE CONTAINER. IT WAS IMPOSSIBLE TO GET IT BACK. PRODUCT NUMBER - 305765. CUSTOMER RESPONSE RECEIVED ON 18-JUN-2024. THE TRANSLATION OF THE CUSTOMER RESPONSE IS: 1. COULD YOU PROVIDE US WITH THE EXACT DATE OF THE INCIDENT (IN DD-MM-YYYY FORMAT)? (B)(6) 2024. 2. PLEASE DESCRIBE ANY PATIENT INJURY, INJURY, COMPLICATION OR ADVERSE CONSEQUENCE OF THE INCIDENT. PATIENT DID NOT RECEIVE FULL DOSE OF ANTIBIOTIC. CUSTOMER RESPONSE RECEIVED ON 16-JUL-2024. 1. WHAT WAS THE FLAW? DURING THE INTRAMUSCULAR INJECTION INTO THE PATIENT, THE NEEDLE DETACHED FROM THE SYRINGE. THE NURSE OBSERVED THE BREAKAGE OF THE EQUIPMENT AT THE NEEDLE THREAD (GREEN PART THAT SCREWS TO THE SYRINGE). 2. WHAT WAS THE OUTCOME FOR THE PATIENT? THE PATIENT DID NOT GET THE FULL DOSE OF THE ANTIBIOTIC. 3. WHICH ANTIBIOTIC WAS GIVEN? BICILLIN HOW MUCH ANTIBIOTIC WAS NOT GIVEN? IT'S DIFFICULT TO ASSESS. 4. HAS ANY ADDITIONAL TREATMENT OR CARE BEEN PROVIDED? NO.

    Description of Event or Problem · 0

    MATERIAL # 305765; BATCH # 1362829. IT WAS REPORTED BY CUSTOMER THAT THE INCIDENT WITH AN ECLIPSE 21G 1 1/2 LOT NEEDLE 1362829 EXP 2026-12-31 THAT OCCURRED AT OUR CLINIC YESTERDAY DURING THE INJECTION OF A MEDICATION TO ONE OF OUR PATIENTS. RCC RECEIVED A COMPLAINT VIA EMAIL. I WOULD LIKE TO REPORT AN INCIDENT WITH AN ECLIPSE 21G 1 1/2 LOT NEEDLE 1362829 EXP 2026-12-31 THAT OCCURRED AT OUR CLINIC YESTERDAY DURING THE INJECTION OF A MEDICATION TO ONE OF OUR PATIENTS. UNFORTUNATELY, THE DEFECTIVE NEEDLE WAS THROWN INTO THE NEEDLE CONTAINER. IT WAS IMPOSSIBLE TO GET IT BACK. PRODUCT NUMBER 305765; CUSTOMER RESPONSE RECEIVED ON 18-JUN-2024: THE TRANSLATION OF THE CUSTOMER RESPONSE IS: COULD YOU PROVIDE US WITH THE EXACT DATE OF THE INCIDENT (IN DD-MM-YYYY FORMAT)? ON (B)(6) 2024. PLEASE DESCRIBE ANY PATIENT INJURY, INJURY, COMPLICATION OR ADVERSE CONSEQUENCE OF THE INCIDENT. PATIENT DID NOT RECEIVE FULL DOSE OF ANTIBIOTIC. CUSTOMER RESPONSE RECEIVED ON 16-JUL-2024. WHAT WAS THE FLAW? DURING THE INTRAMUSCULAR INJECTION INTO THE PATIENT, THE NEEDLE DETACHED FROM THE SYRINGE. THE NURSE OBSERVED THE BREAKAGE OF THE EQUIPMENT AT THE NEEDLE THREAD (GREEN PART THAT SCREWS TO THE SYRINGE). WHAT WAS THE OUTCOME FOR THE PATIENT? THE PATIENT DID NOT GET THE FULL DOSE OF THE ANTIBIOTIC. WHICH ANTIBIOTIC WAS GIVEN? BICILLIN HOW MUCH ANTIBIOTIC WAS NOT GIVEN? IT'S DIFFICULT TO ASSESS. HAS ANY ADDITIONAL TREATMENT OR CARE BEEN PROVIDED? NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    264791 BD NEEDLE ECLIPSE 21X1-1/2 RB HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON 1362829 00382903057658

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown