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

Model Number	460604
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/03/2019
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
The customer states that the feeding tube was found broken in half inside the packaging.
Additional 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
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): COVIDIEN; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• MDR Report Key: 8696266
• Report Number: 9612030-2019-02200
• Device Sequence Number: 16706075
• Product Code: KNT
• UDI-Device Identifier: 10884521067325
• UDI-Public: 10884521067325
• Combination Product (Y/N): N
• Initial Reporter State: PR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/13/2019

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: 460604
• Device Catalogue Number: 460604
• Device Lot Number: 1831801484
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/03/2019
• Supplement Date Received by Manufacturer: 06/03/2019
• Initial Report FDA Received Date: 06/13/2019
• Supplement Report FDA Received Date: 11/13/2019
• Patient Sequence Number: 1