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

Model Number 1186000777T

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

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 Description

The customer reported that the syringe pops off the injector as the patient is being injected.There was no harm to the patient.

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.

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
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 9530130
• MDR Text Key: 173035945
• Report Number: 1282497-2019-08846
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 10884521189645
• UDI-Public: 10884521189645
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 03/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 1186000777T
• Device Catalogue Number: 1186000777T
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/12/2019
• Patient Sequence Number: 1