MAUDE Adverse Event Report: COVIDIEN 12ML SYRINGE LUER LOCK (NS); SYRINGE, PISTON

Model Number	8881112083
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/19/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The incident sample has been requested but to date has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.
Event or Problem Description
Customer reports: particulate and hairs found in 12 ml non sterile syringes.Additional information received states that some of the particulate was free floating.
Additional Manufacturer Narrative
H 3: a device history record (dhr) review was not performed as no lot number was available for evaluation.The syringes themselves were not returned precluding any product conformance conclusion.However, particulate matter that was shipped stored in the voids between nested trays was evaluated.Two of the particulate matter were determined to likely be hair, and three particles were determined to likely originate from cardboard or some type of paper.The root cause investigation could not determine an exact root cause, or the origin of the particulate matter found in the trays.Trending has not identified any adverse trends for this issue.This complaint will be used for tracking and trending purposes.

• Brand Name: 12ML SYRINGE LUER LOCK (NS)
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): COVIDIEN; 815 tek drive; crystal lake IL 60039 9002
• MDR Report Key: 10252735
• Report Number: 1424643-2020-00580
• Device Sequence Number: 2433074
• Product Code: FMF
• UDI-Device Identifier: 10884521010895
• UDI-Public: 10884521010895
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/04/2020

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: No Information
• Device Model Number: 8881112083
• Device Catalogue Number: 8881112083
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/19/2020
• Supplement Date Received by Manufacturer: 06/19/2020
• Initial Report FDA Received Date: 07/09/2020
• Supplement Report FDA Received Date: 09/04/2020
• Patient Sequence Number: 1