MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SYRINGE 5ML LL SP125; PISTON SYRINGE

Catalog Number	309646
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/30/2025
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 5ml ll sp125 had leakage.The following information was provided by the initial reporter: material: 309646, batch#: 5029101.Rcc received a complaint via email.On (b)(6) 2025, we encountered a new incident involving product 309646, lot: 5029101, with an expiration date of december 31, 2029.Two packages of 5 ml syringes were opened, and both were found to be defective: syringe #1: the nurse noticed that the syringe was wet.When she lightly pressed the plunger, the medication splashed and reached her eye.Syringe #2: the nurse observed a persistent leak.Upon closer inspection, she noticed a crack in the plunger and a deposit of floating brown sediment inside the syringe.
Additional Manufacturer Narrative
(b)(4) follow up for device evaluation.Two 5 ml syringes were reported as defective.To support the investigation, one physical sample and two photographs of a 5ml luer-lok syringe from batch 5029101 were submitted for evaluation by the quality team.The sample arrived in an unsealed package containing all relevant product information and exhibited a one-inch crack extending through the barrel.Both photographs depict a loose syringe with an unidentified pink needle attached, positioned next to the packaging top web.The syringe shown in the images appears partially filled with an unknown clear fluid, and the crack in the barrel corresponds to the condition observed in the physical sample.The reported presence of floating brown sediment, as described in the verbatim report, was not visible in either photograph or in the sample provided.The cracked and leaking conditions observed are nonconforming to product specifications and are associated with the assembly process.A review of the device history record for material number 309646, batch 5029101, confirmed that all visual inspections were performed in accordance with requirements, and no quality notifications were recorded for the reported condition.The lot was inspected and accepted based on the approved inspection control plan, released for shipment, and deemed compliant with product specification requirements.To date, no other similar events have been reported for this lot.

• Brand Name: BD SYRINGE 5ML LL SP125
• 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: 23352135
• Report Number: 1213809-2025-00666
• Device Sequence Number: 9019173
• Product Code: FMF
• UDI-Device Identifier: 30382903096467
• UDI-Public: (01)30382903096467(17)291231(10)5029101
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2025

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: 309646
• Device Lot Number: 5029101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2025
• Supplement Date Received by Manufacturer: 11/21/2025
• Initial Report FDA Received Date: 10/21/2025
• Supplement Report FDA Received Date: 11/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/29/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown