MAUDE Adverse Event Report: COVIDIEN FD6050 FDG TUBE 50CM 6.0 FR; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number FD6050

Device Problem Material Twisted/Bent (2981)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/07/2020

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.Udi# is not applicable as this device is not sold in the us.

Event Description

Customer reports: tubes are bent/kinked.

Manufacturer Narrative

A device history record of the reported lot number shows evidence that the product was released according to all established procedures and qa documentation there were no samples received for evaluation however a digital image was provided by the customer and it was evaluated.The photograph confirms the reported condition; the tubes are bet/kinked.An investigation was conducted by reviewing the history and reviewing the production process and storage process in the finished goods warehouse.The conclusion was that the manufacturing process was followed and all tubing at the finished goods storage was in good condition.The distribution center provided additional information that additional tape was used to reinforce the packaging.This tape is no longer used in manufacturing process.The root cause cannot be specifically identified therefore corrective actions will be limited to monitoring the process for any adverse trends that require immediate attention.

• Brand Name: FD6050 FDG TUBE 50CM 6.0 FR
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): COVIDIEN; 117 moo 2, petchkasem rd, samp; nakorn pathom 73110 ; TH 73110
• MDR Report Key: 10505431
• MDR Text Key: 206551643
• Report Number: 8040459-2020-00538
• Device Sequence Number: 1
• Product Code: KNT
• 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: 10/28/2020

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
• Device Operator: No Information
• Device Model Number: FD6050
• Device Catalogue Number: FD6050
• Device Lot Number: 1912216FTB
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 08/07/2020
• Initial Date FDA Received: 09/08/2020
• Supplement Dates Manufacturer Received: 08/07/2020
• Supplement Dates FDA Received: 10/28/2020
• Patient Sequence Number: 1