MAUDE Adverse Event Report: COVIDIEN PVC FEEDING TUBE 5 FR 16IN; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	460802
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/14/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem Description
The customer reported that the end is sealed and the tube is severed into two pieces.The issue was discovered prior to use.The tubing did not appear stuck in the seal of the packaging.There was no patient contact with the product, therefore no harm, injury or delay in treatment.
Additional Manufacturer Narrative
The device history record was reviewed and indicated that the product was released accomplishing all quality standards.One decontaminated sample with lot number 2032236264 was received for evaluation.The returned device was visually inspected, and the reported issue was confirmed; the tubing was trapped in the seal.A corrective and preventative action (capa) is currently open in order to address the failure though a more robust investigation.Any actions resulting from the capa will be designed to prevent the reoccurrence of the reported condition.

• Brand Name: PVC FEEDING TUBE 5 FR 16IN
• 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: 11987424
• Report Number: 9612030-2021-02938
• Device Sequence Number: 14309304
• Product Code: KNT
• UDI-Device Identifier: 10884521067356
• UDI-Public: 10884521067356
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• 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): 09/08/2021

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: 460802
• Device Catalogue Number: 460802
• Device Lot Number: 2032236264
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/17/2021
• Supplement Date Received by Manufacturer: 05/17/2021
• Initial Report FDA Received Date: 06/11/2021
• Supplement Report FDA Received Date: 09/08/2021
• Patient Sequence Number: 1