MAUDE Adverse Event Report: COVIDIEN SALEM SUMP; TUBE, DOUBLE LUMEN FOR INTESTINAL DECOMPRESSION AND/OR INTUBATION

Model Number 8888266122

Device Problem Hole In Material (1293)

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

Event Date 01/11/2017

Event Type  malfunction  

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

The customer states that the patient was connected to the tube for a couple of days and had him at continuous suction.The customer noticed the tube was not working properly and they attempted to see if it was clogged and found a large hole in the tube where the anti-reflux valve meets with the other part of the tube.The hole was very large and the customer was not able to get it to seal.The tube was removed and the patient was monitored.

Manufacturer Narrative

A device history record review could not be performed because a lot number was not received with the complaint.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.A sample was received for evaluation.A visual inspection was performed and the reported issue could not be confirmed.Because the reported issue could not be confirmed, a root cause could not be determined.A corrective action is not applicable at this time.The current process is running according to product specifications meeting quality acceptance criteria.This complaint will be used for tracking and trending purposes.If information is provided in the future, a supplemental report will be issued.

• Brand Name: SALEM SUMP
• Type of Device: TUBE, DOUBLE LUMEN FOR INTESTINAL DECOMPRESSION AND/OR INTUBATION
• Manufacturer (Section D): COVIDIEN; calle 9 sur no. 125 cuidad; no. 125 cuidad; tijuana,na 92173 ; MX 92173
• Manufacturer (Section G): COVIDIEN; calle 9 sur no. 125 cuidad; no. 125 cuidad; tijuana,na 92173 ; MX 92173
• Manufacturer Contact: edward almeida ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 6421513
• MDR Text Key: 70520038
• Report Number: 9612030-2017-05042
• Device Sequence Number: 1
• Product Code: FEG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/19/2017

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: Health Professional
• Device Model Number: 8888266122
• Device Catalogue Number: 8888266122
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/15/2017
• Initial Date FDA Received: 03/21/2017
• Supplement Dates Manufacturer Received: 06/15/2017
• Supplement Dates FDA Received: 10/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1