MAUDE Adverse Event Report: COVIDIEN PVC F TUBE 5FRX36IN W ENFIT; GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS

Model Number 461008E

Device Problem Material Twisted/Bent (2981)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/28/2020

Event Type  malfunction  

Manufacturer Narrative

The complainant indicated that the device will not be returned for evaluation as it has been discarded; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event. as part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product. if additional information or the sample is received, the investigation will be reopened and responded to accordingly.

Event Description

The customer reported that the feeding tube was kinked at the distal end.The tube was bent and very difficult to install in the baby.

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.The sample was not provided for evaluation however one photograph was provided.The reported condition of kinked tubing was confirmed however the condition of stiff tubing cannot be determined without a sample for analysis.The reported condition was not found during the manufacturing process, assembly or the shipping area nor any additional process that could generate it; process was found running according to product specifications meeting quality acceptance criteria.Based on the provided image the root cause analysis indicates that most probable cause of the reported condition is due to damage during sub assembly process packaging and transport.The condition reported by the customer was evaluated against the acceptable quality limit (aql), no action plan is deemed required since the complaint reported represents a rate of 0.007%, below the approved aql of 0.25%.This complaint will be used for tracking and trending purposes.

• Brand Name: PVC F TUBE 5FRX36IN W ENFIT
• Type of Device: GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS
• Manufacturer (Section D): COVIDIEN; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• MDR Report Key: 10033571
• MDR Text Key: 191158284
• Report Number: 9612030-2020-02462
• Device Sequence Number: 1
• Product Code: PIF
• UDI-Device Identifier: 10884521547230
• UDI-Public: 10884521547230
• 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

• Date FDA Received: 05/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 461008E
• Device Catalogue Number: 461008E
• Device Lot Number: 1713616964
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/01/2020
• Patient Sequence Number: 1