BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD SYRINGE INTEGRA 3ML W/NDL 21X1-1/2 RB TW

    MDR report key: 20069053 · Received August 26, 2024

    Report

    Report Number
    1213809-2024-00581
    Event Type
    Injury
    Date Received
    August 26, 2024
    Date of Event
    August 1, 2024
    Report Date
    September 9, 2024
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    MEG
    UDI-DI
    30382903052746
    PMA / PMN Number
    K011103
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) FOLLOW UP MDR FOR DEVICE EVALUATION. THREE PHOTOS WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. ONE IMAGE SHOWS THE TOP WEB GRAPHICS SIDE OF A BLISTER PACKAGE. THE FOLLOWING IMAGE SHOWS AN INTEGRA SYRINGE WITH A CUTTER EXPOSED THROUGH THE STOPPER. THE THIRD IMAGE SHOWS A NEEDLE HUB ATTACHED TO AN INTEGRA SYRINGE, A SPRING, AND THE CUTTER EXPOSED THROUGH THE STOPPER. THE REPORTED DEFECT CANNOT BE CONFIRMED FROM THE PHOTOS PROVIDED. PLEASE NOTE THAT THIS PRODUCT HAS A RETRACTABLE NEEDLE DESIGN. THE METAL CANNULA OF THE NEEDLE RETRACTS INTO THE INNER PLUNGER ROD FOR SAFETY. SINCE NO SAMPLES DISPLAYING THE REPORTED CONDITION WERE RECEIVED, A POTENTIAL ROOT CAUSE COULD NOT BE DEFINED, AND CORRECTIVE ACTIONS ARE UNNECESSARY. A PHYSICAL SAMPLE IS REQUIRED FOR A MORE THOROUGH EVALUATION AND POTENTIAL ROOT CAUSE DETERMINATION. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 2265888. A REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    MATERIAL: 305274 BATCH#: 2265888. IT WAS REPORTED THAT THE BD SYRINGE INTEGRA 3ML W/NDL 21X1-1/2 RB TW NEEDLE PULLED OUT THE HUB. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: RCC RECEIVED A COMPLAINT VIA PHONE. PIR ATTACHED CUSTOMER STATES THAT HIS WIFE WAS GIVING HIM A SHOT IN HIS BUTTOCK AND WHEN THE WIFE WITHDREW, THE NEEDLE WAS MISSING. THE CUSTOMER WENT TO THE ER TO GET AN X-RAY AND THE NEEDLE IS IN HIS BUTTOCK. HE IS GOING TO HAVE TO HAVE SURGERY TO REMOVE IT. PRODUCT NUMBER: 305274; LOT NUMBER: 2265888. CUSTOMER WOULD LIKE AN ACK LETTER AND CLOSURE LETTER. ADDITIONAL INFORMATION PROVIDED: I'M SORRY FOR THE DELAY IN RESPONSE BUT I WILL GIVE YOU THE DETAILS I GAVE FOR THE INITIAL CALL ON (B)(6) 2024. 1. THE EVENT OCCURRED ON 01 AUGUST 2024, AT MY HOME, NEAR MIDNIGHT. MY WIFE WAS GIVING ME A TESTOSTERONE INJECTION IN MY LEFT GLUTEUS MAXIMUS WHEN SHE EXCLAIMED "OH MY GOD! THE NEEDLE JUST DISAPPEARED INTO YOUR BUTT!" 2. WHAT PHYSICAL SAMPLE? THE LEFT-OVER SYRINGE WITH THE NEEDLE MISSING? THAT I HAVE AND IS AT MY HOME. 3. I ARRIVED AT (B)(6) EMERGENCY ROOM AROUND 1 AM ON (B)(6) 2024. THEY WERE UNABLE TO REMOVE THE NEEDLE AND RECOMMENDED I SEE A GENERAL SURGEON. I CONTACTED A GENERAL SURGEON ON (B)(6) 2024 AND WAS TOLD HE HAD NO AVAILABILITY UNTIL (B)(6) 2024 AT 1:45 PM. I SAW DR. (B)(6) ON (B)(6) 2024 AND HE SAID THAT THEY ONLY TOOK X-RAYS AT THE ER AND TO PINPOINT THE EXACT LOCATION A CT SHOULD HAVE BEEN ORDERED. HE WROTE AN ORDER FOR A CT AND TOLD ME MAKE A FOLLOW-UP APPOINTMENT AFTER THE CT. I GOT THE CT THAT DAY AT SETON IMAGING LOCATED ON THE (B)(6) HOSPITAL. I WAS ABLE TO MAKE A FOLLOW-UP APPOINTMENT FOR DR. (B)(6) AT 1 PM ON (B)(6) 2024. 4. I HAVE PICTURES OF THE NEEDLE PACKAGING AND THE SYRINGE WITHOUT THE NEEDLE. PLEASE NOTE: I HAVE A SPINAL CORD INJURY DUE TO A PARACHUTE ACCIDENT WHILE ON ACTIVE DUTY AND HAVE HAD THREE LOWER LUMBAR SURGERIES AND HAD A SPINAL CORD STIMULATOR IMPLANTED TO HELP WITH THE CHRONIC PAIN. I CURRENTLY HAVE ONGOING BACK ISSUES IN THE CERVICAL AND THORACIC SPINAL AREA AND NEED PERIODIC MRI'S FOR THAT AND A SMALL TUMOR ON MY PITUITARY GLAND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1280139 BD SYRINGE INTEGRA 3ML W/NDL 21X1-1/2 RB TW SYRINGE, ANTISTICK MEG BECTON DICKINSON MEDICAL SYSTEMS 2265888 30382903052746

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other