MAUDE Adverse Event Report: COVIDIEN 16FR SALEM W/ GIENTRI PORT WIT; GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS

Model Number 7771610E

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 06/19/2020

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 the tip of the drain broke off when the drain was straightened out by provider from packaging.

• Brand Name: 16FR SALEM W/ GIENTRI PORT WIT
• 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
• MDR Report Key: 10227335
• MDR Text Key: 198739543
• Report Number: 9612030-2020-02518
• Device Sequence Number: 1
• Product Code: PIF
• UDI-Device Identifier: 10884521582736
• UDI-Public: 10884521582736
• 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: 07/02/2020

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
• Device Operator: No Information
• Device Model Number: 7771610E
• Device Catalogue Number: 7771610E
• Device Lot Number: 2004400264
• Initial Date Manufacturer Received: 06/24/2020
• Initial Date FDA Received: 07/02/2020
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1