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

Model Number	1186000777T
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
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.
Event or Problem Description
The customer reported that the syringe pops off the injector as the patient is being injected.There was no harm to the patient.
Additional Manufacturer Narrative
After further review of the complaint details it was determined that this report was submitted in error as the incident does not meet the mdr regulation requirements of a reportable event.
Additional Manufacturer Narrative
A review of the device history record did not indicate any exception that could lead to the reported incident.A sample was not returned to the manufacturing site for evaluation however the supplier conducted a visual check on the retained samples from the lot.There were no deviation deficiencies in any of components.The gasket was assembled and adhered to the plunger without any issue in all samples that were tested.The retained samples were then tested for suction by drawing the water into the syringe until the normal capacity and then injection.As result, no damage or detachment of the component (plunger, gasket) were detected during test.The root cause and corrective/preventative actions (capa) for the reported condition could not be determined based on the retained samples and lack of a returned sample from the customer.

• 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: 9530130
• Report Number: 1282497-2019-08846
• Device Sequence Number: 2334420
• Product Code: FMF
• UDI-Device Identifier: 10884521189645
• UDI-Public: 10884521189645
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/24/2020

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
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 12/12/2019
• Supplement Date Received by Manufacturer: 12/12/2019; 12/12/2019
• Initial Report FDA Received Date: 12/30/2019
• Supplement Report FDA Received Date: 01/14/2020; 03/24/2020
• Patient Sequence Number: 1