MAUDE Adverse Event Report: COVIDIEN SALEM SUMP W/ ARV 16FR. 48IN; TUBE, DOUBLE LUMEN FOR INTESTINAL DECOMPRESSION AND/OR INTUBATION

Model Number 8888266130

Device Problem Fluid/Blood Leak (1250)

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

Event Date 02/18/2019

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 there was a cut or indent on the entry site of the connection causing the feed to leak.The tube was removed and replaced with no harm to the patient.Prior to insertion of the second tube, the health care provider noticed this same issue on two other tubes in the same spot on the device and did not use them.

Manufacturer Narrative

Evaluation summary the device history record (dhr) file was reviewed and no discrepancy was found related to the failure mode reported.Two pictures and five decontaminated samples were received for evaluation.After performing a functional inspection, acceptable results were obtained according to specifications.The condition reported by customer was not observed in the sample; however, damage to the wall between the primary and secondary lumen can be observed in the samples that were returned.The root cause could not be determined for this incident because the physical samples received do not present the issue reported; however, a walk was performed at the manufacturing area with a multi functional team.This walk through identified that a probable root cause for the damage to the wall cut was due to high temperatures at the time of making the cut.Based on the most probable root cause for the condition, a maintenance order was created to install a cooling system.This complaint will be used for tracking and trending purposes.

• Brand Name: SALEM SUMP W/ ARV 16FR. 48IN
• Type of Device: TUBE, DOUBLE LUMEN FOR INTESTINAL DECOMPRESSION AND/OR INTUBATION
• Manufacturer (Section D): COVIDIEN; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• MDR Report Key: 8603413
• MDR Text Key: 145232273
• Report Number: 9612030-2019-02171
• Device Sequence Number: 1
• Product Code: FEG
• UDI-Device Identifier: 10884521004719
• UDI-Public: 10884521004719
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 8888266130
• Device Catalogue Number: 8888266130
• Device Lot Number: 1824500364
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/23/2019
• Patient Sequence Number: 1