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

Catalog Number	302832
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/31/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd syringe 30ml ll s/c 56 had foreign matter.The following information was provided by the initial reporter: material #302832 lot #5176263 verbatim: rcc received a complaint via email.Email(s) attached.We have received a quality complaint on product sold to our customer.Please contact the customer and cc xxx on any future communication.Injuries or adverse event: no item: 302832 quantity affected: 1ea serial/lot number: 5176263 po : 4519197473 are any samples available for return? yes are samples potentially contaminated or biohazard? no reported issue: i opened a sterile syringe and noticed there was a brownish smear on the inside of the syringe (towards the plunger end).I had just changed into clean gloves and had not moved the plunger.I saw it as soon as i removed the wrapper.I was instructed to peel-pack both the syringe and the wrapper it came in.Please include our intermountain case number, (b)(4), with all email communication.
Additional Manufacturer Narrative
A brownish smear was reported on the inside of the syringe.To support the investigation, one sample in an opened blister package was received for evaluation by the quality team.A visual inspection was conducted, revealing an embedded dark-colored speck located approximately ¾ inch from the syringe barrel flange.No additional defects or imperfections were observed.This type of embedded degraded resin typically occurs during startup or intermittently throughout the injection molding process, when degraded resin can break loose and become incorporated into components.A review of the device history record for material number 302832, lot 5176263, was completed.The review did not identify any quality issues during production that could have contributed to the reported condition, nor were there any related quality notifications.All processes and final inspections were performed in accordance 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¿s reported observation has been confirmed.We appreciate you taking the time to bring this observation to our attention.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.

• 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: 23656420
• Report Number: 1911916-2025-00766
• Device Sequence Number: 10123977
• Product Code: FMF
• UDI-Device Identifier: 00382903028320
• UDI-Public: (01)00382903028320(11)250703(17)300531(10)5176263
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: K110771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/06/2025

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: 302832
• Device Lot Number: 5176263
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2025
• Initial Report FDA Received Date: 11/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/03/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown