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

Catalog Number	305064
Medical Device Problem Code	Material Perforation (2205)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	10/08/2025
Type of Reportable Event	Malfunction
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
It was reported that the bd syr 10ml ll w/ndl 18x1-1/2 blunt fill needle went through the shield.The following information was provided by the initial reporter: material#: 305064.Batch#: 5216331.Verbatim: rcc received a complaint via email.Injuries or adverse event: no.Item: 3050694.Quantity affected: 1 each.Serial/lot number: (b)(6).Po: (b)(4) are any samples available for return? yes.Reported issue: accidentally poked by a needle from a sealed syringe- and-needle combo package.The exposure occurred when handling the unopened package, and the needle punctured through the packaging, resulting in a needlestick injury.Customer disposition request: log only.
Additional Manufacturer Narrative
(b)(4) follow up for device evaluation.Two samples of 10ml luer-lok syringes with 18x1-1/2" needle attached (part number 305064, batch 5216331) were received and evaluated.One sample was received in a sealed package with complete product information on the top web and exhibited no defects.The second sample was received in an unsealed package, and the needle shield was broken at the tip, resulting in a live needle condition.This observed condition is non-conforming to product specifications.The potential root cause of the shield damage is associated with the assembly process.Furthermore, a device history record review was completed for provided lot number 5216331.A review showed no rejected inspections or quality issues during the production that could have contributed to the reported defect.

• 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: 23468830
• Report Number: 1213809-2025-00699
• Device Sequence Number: 8727778
• Product Code: FMF
• UDI-Device Identifier: 00382903050642
• UDI-Public: (01)00382903050642(10)5216331
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K110771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/15/2025

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: Other
• Device Catalogue Number: 305064
• Device Lot Number: 5216331
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/13/2025
• Supplement Date Received by Manufacturer: 11/15/2025
• Initial Report FDA Received Date: 11/04/2025
• Supplement Report FDA Received Date: 11/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/04/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown