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

Catalog Number	309580
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B.3.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
It was reported that the bd syringe 3ml ll w/ndl 18x1-1/2 rb had leakage.The following information was provided by the initial reporter: material#: 309580.Batch#: 3355781.Verbatim: rcc received a complaint via email.Item - 309580.Lot - 3355781.Po - (b)(4).Issue - syringes are leaking at midway.
Additional Manufacturer Narrative
(b)(4) follow up for device evaluation.It was reported that some syringes were leaking.To support the investigation, one hundred samples of 3ml luer-lok syringes with 18g 1½-inch needles attached, from lot 3355781, were received for evaluation by the quality team.All samples arrived in sealed packaging with complete product information displayed on the top web.Functional testing was performed on the samples, and no leakage was observed.The returned samples were found to be acceptable and met all product specifications.A review of the device history record for material number 309580, lot 3355781, was also completed.The review confirmed that all visual inspections were conducted in accordance with requirements, and no quality notifications were identified related to the reported condition.The lot was inspected and accepted based on the established inspection control plan, approved for shipment, and determined to be in compliance with product specification requirements.To date, no other similar events have been reported for this lot.

• Brand Name: BD PLASTIPAK 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: 23442235
• Report Number: 1213809-2025-00690
• Device Sequence Number: 21004975
• Product Code: FMF
• UDI-Device Identifier: 00382903095803
• UDI-Public: (01)00382903095803(17)281130(10)3355781
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/06/2025

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: 309580
• Device Lot Number: 3355781
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2025
• Supplement Date Received by Manufacturer: 12/06/2025
• Initial Report FDA Received Date: 10/31/2025
• Supplement Report FDA Received Date: 12/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/21/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown