MAUDE Adverse Event Report: COVIDIEN 5040-02 10FR SPC INSERT SET W CATH X20; CATHETER, SUPRAPUBIC (AND ACCESSORIES)

Model Number 5040-02

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.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 reported, the probe is not well welded in the area where it connects with the forked area and it detached.There was no patient harm.

Manufacturer Narrative

H3 evaluation summary: the device history record (dhr) review showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process of the reported lot.The shafts of these products successfully passed in-process tensile strength testing (tear test) performed to make sure the shafts are not weak.All the results received during this testing were in spec.One sample was received and was forwarded to the supplier of the product for them to complete an investigation.The supplier evaluated the returned sample and found the shaft of the catheter was torn in the area where it connects to the funnel and did not disconnect on its own.Part of the shaft was left inside the funnel.A photo provided by the customer was reviewed by the site and supplier.The sample and photo evaluation could confirm the complaint.This part is one of the smallest sizes of catheter.It is easy to tear the shaft off the funnel if it is pulled with excessive force.It was concluded this is the most likely root cause.A corrective and preventative action (capa) is not deemed necessary at this time.The associated data will be fed into the risk management quarterly report and used for tracking and trending purposes.

• Brand Name: 5040-02 10FR SPC INSERT SET W CATH X20
• Type of Device: CATHETER, SUPRAPUBIC (AND ACCESSORIES)
• Manufacturer (Section D): COVIDIEN; sragh industrial estate, co, t; offaly ; EI
• MDR Report Key: 10424623
• MDR Text Key: 204176009
• Report Number: 9611018-2020-00435
• Device Sequence Number: 1
• Product Code: KOB
• 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
• Report Date: 10/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 5040-02
• Device Catalogue Number: 5040-02
• Device Lot Number: 19F190FHX
• Date Manufacturer Received: 08/06/2020
• Patient Sequence Number: 1