MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SYRINGE INTEGRA 3ML W/NDL 21X1-1/2 RB TW; SYRINGE, ANTISTICK

Catalog Number	305274
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
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.
Event or Problem Description
No additional information was provided.
Additional Manufacturer Narrative
(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.

• Brand Name: BD SYRINGE INTEGRA 3ML W/NDL 21X1-1/2 RB TW
• Common Device Name: SYRINGE, ANTISTICK
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer (Section G): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 20069053
• Report Number: 1213809-2024-00581
• Device Sequence Number: 7821290
• Product Code: MEG
• UDI-Device Identifier: 30382903052746
• UDI-Public: (01)30382903052746(11)220922(17)270831(10)2265888
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K011103
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 305274
• Device Lot Number: 2265888
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2024
• Supplement Date Received by Manufacturer: 09/09/2024
• Initial Report FDA Received Date: 08/26/2024
• Supplement Report FDA Received Date: 09/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/22/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown