MAUDE Adverse Event Report: COVIDIEN 20ML SYR REGULAR LUER TIP RP; SYRINGE, PISTON

Model Number	8881520673
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	04/17/2019
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 syringes are coated with a clear and sticky substance in the packaging and inside the syringe.
Additional Manufacturer Narrative
The device history record was reviewed and indicated that the product was released accomplishing all quality standards.Two samples were received at the manufacturing site for evaluation.A complete investigation was performed.One of the samples was received without a cap.There was white tape over the cap end of the sleeve on both syringe samples received.A visual inspection to the quality inspection standard was conducted.Excessive silicone was identified on the outside diameter of the syringe barrel and inside diameter of the sleeve on one of the syringe samples.A definitive root cause could not be determined.There were no defects identified on the other syringe sample.A corrective action is not applicable at this time.Functional testing and visual inspections are being performed according to our current quality standards and inspection procedures.This complaint will be used for qa tracking and trending purposes.

• Brand Name: 20ML SYR REGULAR LUER TIP RP
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): COVIDIEN; 1222 sherwood rd; norfolk NE 68701
• MDR Report Key: 8636995
• Report Number: 1915484-2019-01054
• Device Sequence Number: 2268528
• Product Code: FMF
• UDI-Device Identifier: 20884521012179
• UDI-Public: 20884521012179
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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
• Report Date (Section B): 11/13/2019

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: 8881520673
• Device Catalogue Number: 8881520673
• Device Lot Number: 825506X
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/16/2019
• Supplement Date Received by Manufacturer: 05/16/2019
• Initial Report FDA Received Date: 05/23/2019
• Supplement Report FDA Received Date: 11/13/2019
• Patient Sequence Number: 1