MAUDE Adverse Event Report: COVIDIEN LP SALEM PUMP; TUBE, DOUBLE LUMEN

Catalog Number 8888266122

Device Problems Material Rupture (1546); Split (2537)

Patient Problem No Information (3190)

Event Date 02/07/2018

Event Type  malfunction  

Event Description

The tubing split/ruptured.

• Brand Name: SALEM PUMP
• Type of Device: TUBE, DOUBLE LUMEN
• Manufacturer (Section D): COVIDIEN LP; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 7330200
• MDR Text Key: 102134886
• Report Number: 7330200
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 8888266122
• Device Lot Number: 1724818064
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/28/2018
• Event Location: Hospital
• Date Report to Manufacturer: 02/28/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 33 YR