MAUDE Adverse Event Report: COVIDIEN 60ML SYRINGE LUER LOCK TIP; SYRINGE, PISTON

Model Number	1186000777
Medical Device Problem Codes	Fluid/Blood Leak (1250); Defective Component (2292)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event.If additional information or the sample is received, the investigation will be reopened and responded to accordingly.
Event or Problem Description
The customer reported, a nurse in the icu found that the syringe plunger was loose and that the product leaked solution.They also reported when the syringe is inverted, the solution flows freely from the tip.There was no patient harm.
Additional Manufacturer Narrative
A device history record could not be reviewed because a lot number could not be provided by the customer.The manufacturing site has not received any samples or photos for evaluation.Therefore, the reported issue could not be confirmed.Without a representative sample(s) or picture(s) being provided, a more complete investigation cannot be performed to the full extent and the reported condition cannot be confirmed.In addition, without a sample or picture, a more definitive root cause cannot be determined at this time.During the assembly of this product, inspectors routinely test samples to ensure acceptance of the reported conditions during the molding, printing, assembly and packaging processes, and to ensure components and finished product that meet all quality inspection standards during the syringe assembly processes.The test results are reviewed for each shop order prior to release to verify that all testing during production was acceptable and within specification limits.The product cannot be accepted unless the acceptable quality level has been met.Based on the information available and the investigation findings, formal corrective/preventative actions are not deemed necessary at this time.Based on the information available and the investigation findings, a formal investigation is not deemed necessary at this time.The reported condition could not confirm a manufacturing deficiency.If additional information is received warranting further analysis, the investigation may be resumed.This complaint will be used for tracking and trending purposes.

• Brand Name: 60ML SYRINGE LUER LOCK TIP
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): COVIDIEN; 1222 sherwood rd; norfolk NE 68701
• MDR Report Key: 9797768
• Report Number: 1915484-2020-01140
• Device Sequence Number: 3003119
• Product Code: FMF
• UDI-Device Identifier: 10884521010864
• UDI-Public: 10884521010864
• 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,Followup
• Report Date (Section B): 05/12/2020

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: 1186000777
• Device Catalogue Number: 1186000777
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/04/2020
• Supplement Date Received by Manufacturer: 03/04/2020
• Initial Report FDA Received Date: 03/06/2020
• Supplement Report FDA Received Date: 05/12/2020
• Patient Sequence Number: 1