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

Model Number 460604

Device Problem Material Perforation (2205)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/10/2020

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.

Event Description

Customer reports: the tube has a hole in the top by the purple port where the syringe attaches.

• 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
• Manufacturer (Section G): COVIDIEN; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• Manufacturer Contact: jill saraiva ; 15 hampshire street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 10459849
• MDR Text Key: 204550206
• Report Number: 9612030-2020-02589
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 10884521067325
• UDI-Public: 10884521067325
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2020
• 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
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/10/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1