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

Model Number	8881501160
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
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 that the plungers were sticking making them difficult to use.
Additional Manufacturer Narrative
H.3.Evaluation summary: the device history record (dhr) for the reported lot number was reviewed showing no issues recorded relating to this customer report.The lot control indicates that product and specification requirements were met with no non-conforming product identified.The manufacturing site received ninety-nine (99) sealed package syringe samples and ninety-three (93) unsealed package syringe samples for evaluation.Five of the unsealed package samples were received with no sheath attached to the syringe assembly.The sheaths were loose in the shuttle.Visual inspection to the quality inspection standard was conducted and found no issues with the plunger sticking.A bent needle was noticed on one of the syringe samples received with the sheath not attached.The manufacturing site lab performed silicone amount testing on a random representative sample from the samples provided.All results confirmed silicone was present and did not exceed the maximum silicone allowed.Control mechanisms are in place to prevent the occurrence and acceptance of the reported condition during molding, printing, assembly, and the packaging processes, and to ensure components and finished product meet all quality inspection standards during the syringe assembly processes.Complaint trends are evaluated during the monthly corrective and preventative action (capa) meeting to determine if a capa is warranted.At this time a capa will not be initiated.This complaint will be used for tracking and trending purposes.

• 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: 9256765
• Report Number: 1915484-2019-01096
• Device Sequence Number: 1879507
• Product Code: FMF
• UDI-Device Identifier: 20884521013954
• UDI-Public: 20884521013954
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 01/28/2020

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: 918215X
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/24/2019
• Supplement Date Received by Manufacturer: 10/24/2019
• Initial Report FDA Received Date: 10/30/2019
• Supplement Report FDA Received Date: 01/28/2020
• Patient Sequence Number: 1