MAUDE Adverse Event Report: COVIDIEN 1ML TB SYR 25G X 5/8 DETACH RP; SYRINGE, PISTON

Model Number	8881501160
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/25/2020
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 when the veterinary tech drew up medication the clear liquid turned cloudy/milky.He drew up another dose in a second syringe and it was also cloudy.The customer thought it might be the drug but when the tech went to draw up a different medication in another syringe, it was also cloudy.The tech then drew up some sterile water in another syringe and the sterile water also turned cloudy.
Additional Manufacturer Narrative
A device history record confirmed that the product was produced accomplishing quality requirements and released according to established procedures.The manufacturing site received sixty-six samples with this customer report.Sixty-four of the samples received were packaged and two samples were unpackaged.A complete investigation was performed.A visual inspection to the quality inspection standard was conducted.No visual abnormalities were identified on the packaged syringe samples.Some cloudiness was observed on the barrel of one of the unpackaged syringe samples and small droplets of clear liquid was observed on the inside of the syringe barrel, indicating the syringe had been used.A leak testing was conducted.The leak test is conducted to verify the syringe draws, holds, and expels fluid properly by inserting the syringe into a rubber block for resistance.All samples passed the leak testing.All testing completed on the returned samples met specifications.The testing included drawing up water into the syringe and visually inspecting each syringe to evaluate for any confirmation of the reported condition.The inspector also waited several moments for each of the returned packaged syringes to ensure there was no color variation of the water and zero syringes displayed any color variation.The water was left in one of the syringes for several weeks to ensure there was no change and there was none noted at several visual inspection intervals.Based on the test results on the return samples, no root cause or probable root cause can be determined.All testing results were aligned with normal testing requirements and results.Process controls are in place to prevent the occurrence and acceptance of the reported conditions during the molding, printing, assembly, and packaging processes, and to ensure components and finished product that meet all quality inspection standards during the syringe assembly processes.In compliance with corporate and local procedures, safeguards are utilized to ensure all processes are controlled and cleaned regularly to minimize any process or product contamination.The control mechanisms are located at the plant and are confirmed on a regular basis to verify continuing efficacy.

• Brand Name: 1ML TB SYR 25G X 5/8 DETACH RP
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): COVIDIEN; 1222 sherwood rd; norfolk NE 68701
• MDR Report Key: 10537353
• Report Number: 1915484-2020-01192
• Device Sequence Number: 11696122
• Product Code: FMF
• UDI-Device Identifier: 20884521013954
• UDI-Public: 20884521013954
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2020

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: 8881501160
• Device Catalogue Number: 8881501160
• Device Lot Number: 012586X
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/25/2020
• Supplement Date Received by Manufacturer: 08/25/2020
• Initial Report FDA Received Date: 09/15/2020
• Supplement Report FDA Received Date: 11/06/2020
• Patient Sequence Number: 1