MAUDE Adverse Event Report: COVIDIEN 35ML SYRINGE LUER LOCK TIP; SYRINGE, PISTON

Model Number	1183500777
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/03/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturing site did not receive any samples with this customer report.Without a sample, an investigation cannot be performed and the defect cannot be confirmed.Without a known lot number, the device history record cannot be reviewed.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.Without a representative sample(s) being provided, a more complete investigation cannot be performed to the full extent and the reported condition cannot be confirmed.If a sample or additional information is received at a later date this investigation will be reopened and updated as needed.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.
Event or Problem Description
The customer reported that the plungers are sticking.

• Brand Name: 35ML SYRINGE LUER LOCK TIP
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): COVIDIEN; 1222 sherwood rd; norfolk NE 68701
• MDR Report Key: 9492410
• Report Number: 1915484-2019-01111
• Device Sequence Number: 10815182
• Product Code: FMF
• UDI-Device Identifier: 10884521010826
• UDI-Public: 10884521010826
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/18/2019

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: 1183500777
• Device Catalogue Number: 1183500777
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/04/2019
• Initial Report FDA Received Date: 12/19/2019
• Patient Sequence Number: 1