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

Model Number	461008E
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/28/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 9612030-2020-02462
• Device Sequence Number: 2986751
• Product Code: PIF
• UDI-Device Identifier: 10884521547230
• UDI-Public: 10884521547230
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: No Information
• Device Model Number: 461008E
• Device Catalogue Number: 461008E
• Device Lot Number: 1713616964
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/01/2020
• Supplement Date Received by Manufacturer: 05/01/2020
• Initial Report FDA Received Date: 05/07/2020
• Supplement Report FDA Received Date: 10/28/2020
• Patient Sequence Number: 1