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

Model Number 1186000777

Device Problems Detachment of Device or Device Component (2907); Material Deformation (2976)

Patient Problem No Patient Involvement (2645)

Event Date 05/02/2019

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.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.

Event Description

The customer reports the luer tip of the syringe was missing and damaged.

Manufacturer Narrative

The manufacturing site received two pictures from the customer.Visual examination of these pictures suggests that the tip is missing from the syringe.The reported condition was confirmed and is classified as a malformed, flash, short shot or damage that would impair function.The device history record (dhr) for the lot control and the shop orders indicate that product and specification requirements were met with no non-conforming product identified relating to this customer report.From the picture it can be confirmed that the tip is not present, but without a physical sample a more definitive root cause cannot be determined at this time.Control mechanisms are in place to prevent the occurrence and acceptance of the reported condition during molding, printing, assembly, and packaging processes, and to ensure components and finished product meet all quality inspection standards during the syringe assembly processes.Based on the information available and the investigation findings, a corrective and preventive action (capa) is not deemed necessary at this time.

• Brand Name: 60ML SYRINGE LUER LOCK TIP
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): COVIDIEN; 1222 sherwood rd; norfolk NE 68701
• MDR Report Key: 8607372
• MDR Text Key: 145032731
• Report Number: 1915484-2019-01051
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 10884521010864
• UDI-Public: 10884521010864
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 09/26/2019

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
• Device Operator: No Information
• Device Model Number: 1186000777
• Device Catalogue Number: 1186000777
• Device Lot Number: 900131X
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 05/02/2019
• Initial Date FDA Received: 05/14/2019
• Supplement Dates Manufacturer Received: 05/02/2019
• Supplement Dates FDA Received: 09/26/2019
• Patient Sequence Number: 1