MAUDE Adverse Event Report: COVIDIEN PVC FEEDING TUBE 8 FR 16; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number 460604

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Date 06/03/2019

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 states that the feeding tube was found broken in half inside the packaging.

Manufacturer Narrative

The device history record was reviewed and indicated that the product was released accomplishing all quality standards.One unused sample was received at the manufacturing site for evaluation.In addition, two photos were provided for the investigation.Upon a visual evaluation, the reported condition was confirmed; a cut in the tube was observed.A multifunctional team reviewed the complaints and conditions; as a result, a formal investigation and corrective/preventative action (capa) was initiated to investigate and address the condition of ¿tubing trapped in seal¿.The results will be documented, and corrective actions implemented per the findings of the final report.This complaint will be used for qa tracking and trending purposes.

• Brand Name: PVC FEEDING TUBE 8 FR 16
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): COVIDIEN; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• MDR Report Key: 8696266
• MDR Text Key: 147911835
• Report Number: 9612030-2019-02200
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 10884521067325
• UDI-Public: 10884521067325
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 11/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 460604
• Device Catalogue Number: 460604
• Device Lot Number: 1831801484
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/03/2019
• Patient Sequence Number: 1