MAUDE Adverse Event Report: COVIDIEN SALEM SUMP PVC TUBE 14FR 48IN; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number 8888264945

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Date 08/04/2020

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 the rn opened a new ng tube package prior to insertion and noticed that the tip was partially broken off.

Manufacturer Narrative

H 3 evaluation summary: a device history record (dhr) review could not be performed because a lot number was not available.One sample was received for evaluation.After performing a visual inspection, the reported condition was not observed in the sample.A root cause could not be determined because the reported condition was not confirmed in the received sample.All process and controls were found properly followed, including sub-assemblies, finished product assembly, and packaging and inspections performed to the product.There were no abnormal conditions found that could trigger the reported condition.No action plan is deemed required.The current process is running according to product specifications, meeting quality acceptance criteria.However, as a precautionary measure, the production personnel were notified about the reported condition for manufacturing awareness.The manufacturing site will continue monitoring the process for any adverse trends that require immediate attention.This complaint will be used for tracking and trending purposes.

• Brand Name: SALEM SUMP PVC TUBE 14FR 48IN
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): COVIDIEN; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• MDR Report Key: 10403824
• MDR Text Key: 202814800
• Report Number: 9612030-2020-02565
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 10884521007697
• UDI-Public: 10884521007697
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 12/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 8888264945
• Device Catalogue Number: 8888264945
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/10/2020
• Patient Sequence Number: 1