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

Catalog Number	302832
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/06/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.B3.The date received by manufacturer has been used for this field.
Event or Problem Description
It is reported foreign matter.Description: pharmacy technician discovered what appears to be a circular substance adhered to the end of the plunger on the inside of the syringe.Additional information: diltiazem injectable solution.The fm was discovered when medication was pulled up in the syringe.
Additional Manufacturer Narrative
(b)(4) follow up for device evaluation.A circular substance was reported to be adhered to the plunger tip on the interior of the syringe.To support the investigation, one sample without blister packaging and one photograph were received by the quality team for evaluation.A visual inspection was performed.The syringe rubber stopper exhibited a droplet of lubricant approximately 3 32 inch in size.The provided photograph corresponded to the returned sample.No other defects or imperfections were observed.The lubricant is medical grade and is applied to the inner wall of the syringe barrel and the rubber stopper during manufacturing.A device history record review was completed for material number 302832, lot 5317444.The review did not reveal any quality issues during production that could have contributed to the reported condition.There were no related quality notifications.All processes and final inspections complied with specification requirements.To date, no other similar events have been reported for this lot.Based on the investigation and analysis of the returned sample, the customer reported condition was confirmed, however, it is considered an acceptable imperfection.
Event or Problem Description
No harm or negative impact.

• 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: 24472049
• Report Number: 1911916-2026-00093
• Device Sequence Number: 13339343
• Product Code: FMF
• UDI-Device Identifier: 00382903028320
• UDI-Public: (01)00382903028320
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 03/05/2026

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: 302832
• Device Lot Number: 5317444
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 02/26/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2026
• Supplement Date Received by Manufacturer: 03/05/2026
• Initial Report FDA Received Date: 02/27/2026
• Supplement Report FDA Received Date: 03/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/13/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown