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

Catalog Number	8881135609
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/17/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd mon syringe barrel assembly had foreign matter.The following information was provided by the initial reporter with the verbatim: a monoject syringe with a brown particle found inside the syringe wall.Please see product info below.
Additional Manufacturer Narrative
B3.The date received by manufacturer has been used for this field.H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
It was reported, by the customer, that the monoject syringe had a brown particle found inside the syringe wall.Two photos of monoject syringe, item number (b)(4), was submitted for quality investigation.The customer complaint of foreign matter was verified by visual inspection.Evaluation of the photos submitted indicate contamination was observed inside the syringe.The investigation was forwarded to the supplier for further investigation and determination of the root cause of the issue.The supplier determined that the probable root cause would be that the process was not followed correctly.Production personnel was notified of the condition reported and they will continue to monitor customer complaints and feedback notifications for adverse trends that require immediate attention.A device history record review for showed that all acceptance criteria inspection per established sampling levels were within acceptable limits during the production process.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.H3 other text : see narrative below.
Event or Problem Description
No additional information was provided.Mat#:8881135609.Lot#: 2213015864.It was reported by customer that monoject syringe with a brown particle found inside the syringe wall.Verbatim: rcc received the complaint via email.Email as attached.A monoject syringe with a brown particle found inside the syringe wall.Please see product info below: ref 8881135609.Lot# 2213015864.Quantity: (b)(4) syringe.Wed (b)(6) 2023 9:16 am.Hello, please see below for requested info: 1.No adverse events, so none reported due to incident.2.See below for photos.3.Date of event: 08/15/2023.

• Brand Name: 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; parque industrial el florido; franklin lakes NJ 07417
• Manufacturer Contact: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17711076
• Report Number: 9616066-2023-01851
• Device Sequence Number: 2251304
• Product Code: FPA
• UDI-Device Identifier: 20884521155746
• UDI-Public: (01)20884521155746
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 12/07/2023

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: 2213015864
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/17/2023
• Supplement Date Received by Manufacturer: 12/07/2023
• Initial Report FDA Received Date: 09/08/2023
• Supplement Report FDA Received Date: 12/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/21/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown