MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD LUER-LOK; PISTON SYRINGE

Catalog Number	302830
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that syringes were leaking past the plunger.Because a physical sample was not returned, a comprehensive evaluation could not be performed.To support the investigation, three photographs were reviewed by the quality team.Two images depict a syringe containing a red solution with residue visible past the rubber stopper; the third shows the top web of a packaging blister.No additional information could be obtained from the photographs.A device history record review was completed for material number: 302830, lot: 5282805.The review did not identify any quality issues during production that could have contributed to the reported condition, and there were no related quality notifications.All manufacturing processes and final inspections met specification requirements.To date, no other similar events have been reported for this lot.Based on the photographic evidence, the reported condition was corroborated.However, in the absence of the physical sample, a definitive root cause could not be determined.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
It was reported that the bd syringe 20ml ll s/c 48 had leakage past the stopper.The following information was provided by the initial reporter: material#: 302830, batch#: 5282805.Rcc received a complaint via email.The xxxx location thinks they received a bad batch of 20ml syringes, they are all leaking down past the plunger.See info and pics below.Please advise of next steps.Bd, lot: 5282805, exp: 9/30/2030.Reorder number: (b)(4).Additional information: date of event: 10-12-2025.Patient impact: no impact to patient, changed out syringe in iv room before going out to administer to patient at chair side.

• Brand Name: BD LUER-LOK
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer (Section G): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 23939646
• Report Number: 1911916-2025-00822
• Device Sequence Number: 9038875
• Product Code: FMF
• UDI-Device Identifier: 00382903028306
• UDI-Public: (01)00382903028306(11)251015(17)300930(10)5282805
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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
• Report Date (Section B): 12/15/2025

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: 302830
• Device Lot Number: 5282805
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2025
• Initial Report FDA Received Date: 01/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/15/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown