MAUDE Adverse Event Report: COVIDIEN 412 CURVED TIP SYRINGE; SYRINGE, PISTON

Model Number	8881412012
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/16/2020
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.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.
Event or Problem Description
The customer reported the device seemed to have a condensation or a film layer inside the syringe.
Additional Manufacturer Narrative
A review of the device history record revealed no discrepancies that may have contributed to the reported condition.All quality assurance testing is performed during the manufacturing of the product met specification requirements.Sixteen syringes were returned in a large, plastic zip-loc bag identified with a post-it note containing the part number and lot number.A review of the samples has identified no condensation; however, silicone is present.Silicone is used in the production process.The root cause for the presence of a film layer inside these syringes has been found to be a step in the manufacturing process in which silicone is added to facilitate actuation.Based on the information available and the investigation findings, a formal investigation is not deemed necessary at this time.The reported condition could not confirm a manufacturing deficiency.If additional information is received warranting further analysis, the investigation may be resumed.This complaint will be used for tracking and trending purposes.

• Brand Name: 412 CURVED TIP SYRINGE
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): COVIDIEN; 815 tek drive; crystal lake IL 60039 9002
• MDR Report Key: 9608692
• Report Number: 1424643-2020-00564
• Device Sequence Number: 13599445
• Product Code: FMF
• UDI-Device Identifier: 10884521002494
• UDI-Public: 10884521002494
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/20/2020

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: 8881412012
• Device Catalogue Number: 8881412012
• Device Lot Number: 18K17963X
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/16/2020
• Supplement Date Received by Manufacturer: 01/16/2020; 01/16/2020
• Initial Report FDA Received Date: 01/20/2020
• Supplement Report FDA Received Date: 03/17/2020; 04/20/2020
• Patient Sequence Number: 1