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

Catalog Number	305062
Medical Device Problem Code	Material Perforation (2205)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	12/17/2025
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 syringe blunt fill 5ml ll w/ndl 18x1-1/2 needle went through the shield.The following information was provided by the initial reporter: material #305062 batch #5297089.Rcc received a complaint via email.I want to report an incident that happened yesterday (b)(6) 2025 at (b)(6).An employee was stocking syringes and one of the needles pocked his middle finger in the open palm side of his left hand.It was an unused unopened needle (see attached pictures) with a defective cap on the needle.The syringe is sequestered.Supplier: (b)(4).
Additional Manufacturer Narrative
(b)(4) - supplemental mdr - needle through shield.One sample and two photos of a 5 ml luer lok syringe with an 18 x 1½" needle attached (part number 305062, batch 5297089) were received and reviewed.The physical sample arrived in an unsealed package containing all required product information and showed a broken needle shield at the end, leaving the needle tip exposed.The accompanying photos include one showing the top web of the sealed package with all applicable labeling and another showing the syringe inside the sealed package with the needle shield broken in the same manner.This condition is non conforming to product specifications, and the likely root cause of the broken shield is associated with the assembly process.A device history record review was completed for material number 305062, lot 5297089.All in process and final visual inspections were performed as required, and no quality notifications related to the reported condition were identified.The lot met acceptance criteria per the inspection control plan, was approved for shipment, and is in compliance with applicable product specifications.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured in trend reports and monitored monthly, and our business team regularly reviews the collected data to identify any emerging trends.
Event or Problem Description
No additional information was provided.

• Brand Name: 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: 23998544
• Report Number: 1213809-2025-00811
• Device Sequence Number: 16084798
• Product Code: FMF
• UDI-Device Identifier: 00382903050628
• UDI-Public: (01)00382903050628(17)300930(10)5297089
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 02/03/2026

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: 305062
• Device Lot Number: 5297089
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2025
• Supplement Date Received by Manufacturer: 02/03/2026
• Initial Report FDA Received Date: 01/07/2026
• Supplement Report FDA Received Date: 02/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/24/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown