MAUDE Adverse Event Report: BECTON DICKINSON MON SYRINGE BARREL ASSEMBLY; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	8881135609
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Material inspection found multiple syringe lots with fibers and particles.
Additional Manufacturer Narrative
The customer reported syringes with particles and fibers, and 6 samples were returned, all of material 8881135609, with two reported lots of 2431701064 & 2429606364.Upon initial visual examination, the sets verified the failure of foreign matter.There were two sets each with the following reports: white fibers, dark fibers, and white particulates.All six of the syringes confirmed the failure reported.It was not reported or detailed which lots went with which syringes, and those details remain unknown.The details of the report were relayed to the supplier of the syringe, and a case has been created.The root cause for the foreign matter on the syringes is unknown.Device history record for cardinal supplied parts is owned by the supplier of the syringe.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.
Additional Manufacturer Narrative
The customer reported syringes with particles and fibers, and 6 samples were returned, all of material 8881135609, with two reported lots of 2431701064 & 2429606364.Upon initial visual examination, the sets verified the failure of foreign matter.There were two sets each with the following reports: white fibers, dark fibers, and white particulates.All six of the syringes confirmed the failure reported.It was not reported or detailed which lots went with which syringes, and those details remain unknown.The details of the report were relayed to the supplier of the syringe, and a case has been created.The root cause for the foreign matter on the syringes is unknown.In this case, the device history record for supplied parts is owned by the supplier of the syringe.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.Your assistance in this matter has been helpful in trend identification and supporting our commitment to continuous quality improvement.
Event or Problem Description
No additional information was provided.

• Brand Name: MON SYRINGE BARREL ASSEMBLY
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 23098432
• Report Number: 2243072-2025-01180
• Device Sequence Number: 15644815
• Product Code: FPA
• UDI-Device Identifier: 20192253030652
• UDI-Public: (01)20192253030652
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/20/2025

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: Other
• Device Catalogue Number: 8881135609
• Device Lot Number: 2431701064
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2025
• Supplement Date Received by Manufacturer: 10/20/2025
• Initial Report FDA Received Date: 09/19/2025
• Supplement Report FDA Received Date: 11/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/16/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown