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

Model Number	1186000777T
Medical Device Problem Code	Component or Accessory Incompatibility (2897)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/11/2020
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.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.If additional information or the sample is received, the investigation will be reopened and responded to accordingly.
Event or Problem Description
The customer reported that medication can escape the syringe through the plunger.
Additional Manufacturer Narrative
The device history record was reviewed and indicated that the product was released accomplishing all quality standards.Inspection records at both the process stage and the final releasing stage were also checked and there was no damaging or deformation in any components found.Samples were not returned for evaluation by the customer.However, the supplier performed testing and investigation on ten retained samples from the lot number reported.The visual check indicated that there was no deformation or damaging in any components; the gaskets were assembled to the plungers completely and no abnormality in the seals of gasket contacting with the barrel was found.Furthermore, the dimension at the seals of the gaskets of the retained samples were checked and all measured results were within specifications.A leakage test was performed on the retained samples and passed per iso 7886-1 requirements; no leaks passed the seals of the gasket for all samples tested.Since the customer¿s samples were not returned for evaluation and the retained samples, as described above, did not reveal leakage through the plunger we are unable to identify a root cause from a product non-conformity therefore no correction actions will be implemented at this time.This complaint will be used for tracking and trending purposes.

• Brand Name: 60ML SYRINGE LUER LOCK TIP SYR
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 10237537
• Report Number: 1282497-2020-09178
• Device Sequence Number: 18981272
• Product Code: FMF
• UDI-Device Identifier: 10884521189645
• UDI-Public: 10884521189645
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 09/02/2020

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: 1186000777T
• Device Catalogue Number: 1186000777T
• Device Lot Number: 18H17
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/11/2020
• Supplement Date Received by Manufacturer: 06/11/2020
• Initial Report FDA Received Date: 07/06/2020
• Supplement Report FDA Received Date: 09/02/2020
• Patient Sequence Number: 1