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

Model Number	8881501160
Medical Device Problem Code	Nonstandard Device (1420)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/25/2019
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 plunger is sticky and hard to pull back.
Additional Manufacturer Narrative
The device history record was reviewed and indicated that the product was released accomplishing all quality standards.The manufacturing site received eleven sealed package samples for evaluation.A complete investigation was performed.Visual inspection to the quality inspection standard was conducted and no defects were identified.The lab performed plunger activation force testing on the eleven samples received and all samples were found to be within specification.The reported condition could not be confirmed.A root cause could not be determined as the reported issue was not confirmed.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: 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: 8854593
• Report Number: 1915484-2019-01072
• Device Sequence Number: 19432274
• Product Code: FMF
• UDI-Device Identifier: 20884521013954
• UDI-Public: 20884521013954
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2019

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: 8881501160
• Device Catalogue Number: 8881501160
• Device Lot Number: 914044X
• Initial Date Received by Manufacturer: 07/25/2019
• Supplement Date Received by Manufacturer: 07/25/2019
• Initial Report FDA Received Date: 08/02/2019
• Supplement Report FDA Received Date: 11/21/2019
• Patient Sequence Number: 1