MAUDE Adverse Event Report: COVIDIEN POLYUR F T 6.5FRX36IN W ENFIT; GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS

Model Number 461438E

Device Problem Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/06/2020

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.  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 reported that they received the tube with a defective tip, it looked like it was cut across.

• Brand Name: POLYUR F T 6.5FRX36IN W ENFIT
• Type of Device: GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS
• 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: 10111933
• MDR Text Key: 195414268
• Report Number: 9612030-2020-02484
• Device Sequence Number: 1
• Product Code: PIF
• UDI-Device Identifier: 10884521547148
• UDI-Public: 10884521547148
• 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,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 461438E
• Device Catalogue Number: 461438E
• Device Lot Number: 1821903564
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/06/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1