MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD INTEGRA; PISTON SYRINGE

Catalog Number 305270

Device Problem Defective Component (2292)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/29/2023

Event Type  Injury  

Event Description

It was reported that the bd integra syringe needle pulled out of hub.The following information was provided by the initial reporter: "my name is xxx, and last night i had my weekly testosterone injection done with one of your retractable needles! once we got closer to the end of the liquid, there was a "pop" noise, and the needle became detached from the syringe itself.It was sticking out of me, but i unfortunately passed out once my mother had ahold of it with tweezers.It worked its way deeper, and the emergency room doctor said that unless it gets infected, to just leave it, but that it will certainly cause pain and discomfort due to the size.I was wondering if this was a common issue with your product? or if you guys had any advice on the matter? i have included an images of the syringe and the packaging label as well.".

Manufacturer Narrative

E.1.Address was not located and il was used.H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Manufacturer Narrative

(b)(4) : follow up mdr for device evaluation three photos were provided.Two of the photos show a packaging blister.Another photo shows a syringe with a needle hub connected to it.The needle hub has no needle.No other information can be obtained from the photos.Based on the investigation and with the sample analysis the symptom reported by the customer is confirmed.We will continue monitoring the complaint trend for the product and symptom.With no actual sample analysis, a probable root cause could not be offered.A device history record review was completed for provided lot number 2244628 showing no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.We appreciate you taking the time to bring this observation to our attention.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.

Event Description

No additional information.

• Brand Name: BD INTEGRA
• Type of Device: PISTON SYRINGE
• 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: 18192051
• MDR Text Key: 328805137
• Report Number: 1213809-2023-01332
• Device Sequence Number: 1
• Product Code: MEG
• UDI-Device Identifier: 30382903052708
• UDI-Public: (01)30382903052708
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K011103
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 305270
• Device Lot Number: 2244628
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/03/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other