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)
Date of Event	10/04/2019
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 that the plungers are sticky which is very hard to draw blood or give injections.
Additional Manufacturer Narrative
H 3 evaluation summary the device history record (dhr) for the reported lot was reviewed.During the manufacturing of the syringe assemblies, syringes were visually and physically tested with no issues recorded relating to this customer report.The dhr for the lot control indicates that product and specification requirements were met with no non-conforming product identified relating to this customer report.The dhr for the representative samples sent was also reviewed showing no issues recorded relating to this customer report.The manufacturing site received sealed, packaged syringe samples and unsealed, packaged samples identified with the reported lot and a representative lot.A complete investigation was performed.Visual inspection of the sealed package samples showed no issues related to the customers complaint of sticking plungers.The lab performed a 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.As a result of a thorough investigation and product analysis, there are no confirmed issues in relation to the reported condition.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: 9191081
• Report Number: 1915484-2019-01094
• Device Sequence Number: 14090722
• 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): 02/18/2020

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: 920347X
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/07/2019
• Supplement Date Received by Manufacturer: 10/07/2019
• Initial Report FDA Received Date: 10/15/2019
• Supplement Report FDA Received Date: 02/18/2020
• Patient Sequence Number: 1