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

Catalog Number	309570
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2025
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 syringe 3ml ll w/ndl 25x5/8 rb had leakage past the stopper.The following information was provided by the initial reporter: material # 309570 batch # unknown verbatim: rcc received a complaint via phone.Pir attached.Product complaint canada complaint ref 309570 lot unknown.Issue: so when administering injection medication leaked behind the plunger.Sample actual device was discarded but pictures are available doe (b)(6) 2025 no pt harm.
Additional Manufacturer Narrative
(b)(4) - supplemental mdr - leakage past stopper.A report was received indicating that medication had leaked behind the plunger of a syringe.To support the investigation, three photographs were submitted to the quality team for evaluation.The images depict a single 3ml luer-lok syringe with a 25g 5/8" needle attached, positioned next to its packaging, which displays the top web graphics.Based on the packaging design shown in the photographs, the syringe was manufactured prior to august 2005 and has been expired for over fifteen years.Bd does not guarantee the efficacy or safety of expired products.Given the information available, it is strongly recommended that product from this batch not be used.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 or Problem Description
No additional information was provided.

• Brand Name: 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: 22572033
• Report Number: 1213809-2025-00491
• Device Sequence Number: 13186673
• Product Code: FMF
• UDI-Device Identifier: 00382903095704
• UDI-Public: (01)00382903095704
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K110771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2025

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: Health Professional
• Device Catalogue Number: 309570
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2025
• Supplement Date Received by Manufacturer: 09/11/2025
• Initial Report FDA Received Date: 07/22/2025
• Supplement Report FDA Received Date: 09/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown