MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS S.A. DE C.V. BD BD MON SYRINGE BARREL ASSEMBLY; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	8881135609
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/04/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
It was reported that bd mon syringe barrel assembly had foreign matter within fluid pathway the following information was received by the initial reporter with the following verbatim rcc received a complaint via email.Email(s) attached i am (b)(4), qa supervisor with staq pharma.We recently discovered a trend in high defect rates in three of our batches with regards to particles/fibers found adhered to the stopper on bd monoject syringes, lot # 2220719464.Have you had any complaints or issues with this lot number of syringes?.
Event or Problem Description
No additional information was provided.
Additional Manufacturer Narrative
The customer reported foreign matter in the stopper of syringes, and returned 140 unopened samples of material 8881135609, lot 2220719464.The syringes were visually examined, and the rubber plunger was found to have unknown substance on the tip.The complaint of foreign matter was verified.The supplier was notified, but they were unable to provide the device history record or root cause analysis.They assured that responsible technical personnel will investigate the causes.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.

• Brand Name: BD BD MON SYRINGE BARREL ASSEMBLY
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): SISTEMAS MEDICOS ALARIS S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• 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: 19402441
• Report Number: 9616066-2024-00794
• Device Sequence Number: 20569509
• Product Code: FPA
• UDI-Device Identifier: 20884521155746
• UDI-Public: (01)20884521155746
• 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: User Facility
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2024

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: 2220719464
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2024
• Supplement Date Received by Manufacturer: 09/17/2024
• Initial Report FDA Received Date: 05/27/2024
• Supplement Report FDA Received Date: 09/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/21/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown