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

Catalog Number	302830
Medical Device Problem Codes	Break (1069); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/13/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported, nurse noted that the back of the syringe was shattered and medication was leaking out.
Additional Manufacturer Narrative
H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.E1.Address information was not provided; therefore, (b)(6) was used as the state.
Additional Manufacturer Narrative
(b)(4) follow up for device evaluation.It was reported that the back of the syringe was shattered and medication was leaking.To support the investigation, one sample received in an opened blister package was provided to the quality team for evaluation.A visual inspection confirmed damage to the syringe barrel, including cracks.No additional defects or irregularities were observed.This condition may be consistent with a jam occurring during the syringe assembly process.A device history record review was completed for material number 302830, lot 5322263.The review identified no quality issues during production that could have contributed to the reported condition, and no related quality notifications were identified.All in process checks and final inspections met specification requirements.Verification of the assembly process was also performed; rail and conveyor alignment were confirmed to be correct, and product flow was observed to be acceptable.To date, no similar events have been reported for this lot.Based on the investigation results and the analysis of the returned sample, the customer reported symptom is confirmed.

• Brand Name: LUER-LOK
• Common Device Name: SYRINGE, PISTON
• 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: 24912297
• Report Number: 1911916-2026-00180
• Device Sequence Number: 18610441
• Product Code: FMF
• UDI-Device Identifier: 00382903028306
• UDI-Public: (01)00382903028306(11)251120(17)301031(10)5322263
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 04/29/2026

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: 5322263
• 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: 04/14/2026
• Supplement Date Received by Manufacturer: 04/29/2026
• Initial Report FDA Received Date: 04/17/2026
• Supplement Report FDA Received Date: 04/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/20/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown