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

Catalog Number	309646
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
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
H3: 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 5 ml ll sp125 had foreign matter.The following information was provided by the initial reporter: material #: 309646; batch#: 5029101.It was reported by a customer that they opened two packages of 5 ml syringes.One syringe was noted that the syringe was wet.When pressing lightly on the plunger, the medication splashed and splashed into her eye and another syringe was noticed a persistent leak.Upon closer inspection, she observed a crack in the plunger, as well as a deposit of floating brown sediment inside the syringe.Verbatim: rcc received a complaint via email.Email(s) attached.On 09/30/2025, we encountered a new incident with product 309646, batch 5029101, with an expiration date of 12/31/2029.Two packages of 5 ml syringes were opened, and they were found to be defective: syringe #1: the nurse noted that the syringe was wet.When pressing lightly on the plunger, the medication splashed and splashed into her eye.Syringe #2: the nurse noticed a persistent leak.Upon closer inspection, she observed a crack in the plunger, as well as a deposit of floating brown sediment inside the syringe.Attached, you will find photos illustrating these anomalies.Please let us know the procedure to follow for handling this non-conformity (replacement, return, analysis, etc.).Best regards, looking forward to your response, best regards.
Event or Problem Description
(b)(4) is a duplicate complaint and will be cancelled.
Additional Manufacturer Narrative
(b)(4) follow up report for correction.This complaint was found to be a duplicate after the mdr was submitted.

• 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: 23319020
• Report Number: 1213809-2025-00654
• Device Sequence Number: 20117610
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/11/2025

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: 309646
• Device Lot Number: 5029101
• Was Device Available for Evaluation?: No
• 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: 11/11/2025
• Initial Report FDA Received Date: 10/16/2025
• Supplement Report FDA Received Date: 11/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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