MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SYRINGE INTEGRA 3ML W/NDL 23X1 RB; SYRINGE, ANTISTICK

Catalog Number	305271
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Unintended Radiation Exposure (4565)
Date of Event	09/08/2024
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 # 305271.Batch # unknown.It was reported that the bd syringe integra 3ml w/ndl 23x1 rb needle pulled out of the hub.Verbatim: rcc received a complaint via phone.Pir attached.Product complaint: ref: 305271 lot: unknown.Issue: using to administer testostrone when pushing plunger, the needle came out and went into pts leg.Doe: (b)(6) 2023.Taken to (b)(6).Did x-ray was unable to locate the needle and a catscan unable to detect the needle all occurred on the (b)(6) 2023.Pcp suggested to conduct ultrasound pts wife said husband does not want to ultrasound.Sample: yes, retained syringe is available please send sample return kit.Additional information: first error i found in your inquiry is the date.The correct date is (b)(6) 2024 the needle is a bd integra syringe, 3ml 23g x 1.Ref: 305271, numbers on the bottom of the packaging are as follows; (b)(4), 2026-02-28 cav.08, lot, 1054566.This syringe was filled with 100mg of testosterone cypionate usp 200 mg.The needle was inserted into the left thigh, the plunger was pushed to release the medicine.The needle released itself from the syringe and forcefully embedded itself into the thigh.
Additional Manufacturer Narrative
(b)(4) - supplemental mdr - needle pulled out of hub.Since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.No root cause can be determined as no samples were received.Furthermore, a device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.
Event or Problem Description
No additional information was provided.

• Brand Name: BD SYRINGE INTEGRA 3ML W/NDL 23X1 RB
• 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: 20447272
• Report Number: 1213809-2024-00711
• Device Sequence Number: 7007813
• Product Code: MEG
• UDI-Device Identifier: 30382903052715
• UDI-Public: (01)30382903052715
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K011103
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2024

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 Expiration Date: 02/28/2026
• Device Catalogue Number: 305271
• Device Lot Number: 1054566
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/23/2024
• Supplement Date Received by Manufacturer: 12/05/2024
• Initial Report FDA Received Date: 10/14/2024
• Supplement Report FDA Received Date: 12/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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