MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD LUER-LOK; PISTON SYRINGE

Catalog Number	309657
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Codes	Needle Stick/Puncture (2462); Insufficient Information (4580)
Date of Event	04/16/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd syringe 3ml ll 200 s/c luer was cracked / damaged / deformed.Good afternoon, on 2/26/2026, we had a safety event reported for item#: 309657 (bd luer-lok syringe sterile, single use, 3 ml).Let¿s identify this as, as a reference number.The defective product is not available for pick up.We have multiple instances about this same product, please read the event details below.Based on the information provided below, could you start a product quality report? reported date 2/26/2026; event date: 2/26/2026; item numbers: 309657; lot number: 5317823; item available for pick up? no; picture: no; patient harm: none.Event details: ¿in the last 2 weeks our stocked par 3 ml luer lock syringe tip seem to be stripped and not holding needle locked in placed.This issue resulted in a medical staff needle stick.Lot#: 5317823 ref#: 309657.¿.
Additional Manufacturer Narrative
B3.The date received by manufacturer has been used for this field.H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
Investigation summary: since no samples displaying the reported condition were received a potential root cause could not be defined and corrective actions are not necessary.A physical sample is required for a more thorough evaluation and potential root cause determination.We will continue monitoring the complaint trend for the product and symptom.The complaint was not confirmed, and no capa evaluation was required.This complaint type will continue to be trended within the post-market surveillance process, and any determined escalation will be managed there.

• Brand Name: BD LUER-LOK
• Common Device Name: 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: 25125079
• Report Number: 1213809-2026-00242
• Device Sequence Number: 16134705
• Product Code: FMF
• UDI-Device Identifier: 30382903096573
• UDI-Public: (01)30382903096573
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K110771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 309657
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2026
• Supplement Date Received by Manufacturer: 06/03/2026
• Initial Report FDA Received Date: 05/08/2026
• Supplement Report FDA Received Date: 06/05/2026
• 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