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

Model Number 8888264945

Device Problems Crack (1135); Suction Problem (2170)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/30/2019

Event Type  malfunction  

Manufacturer Narrative

The complainant indicated that the device will not be returned for evaluation as it was discarded; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event.  if additional information or the sample is received, the investigation will be reopened and responded to accordingly.

Event Description

The customer reported that there was a suspected fine crack in the tubing, resulting in ineffective aspiration of the tube with a simultaneous faint sound of air.The patient had the tube inserted the day prior.The customer further stated the product failed to aspirate the gastric fluids because it was split and spilling out of the sides.The tubing had to be changed.There was no patient injury reported.

• 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
• 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 ; 5086183640
• MDR Report Key: 9126331
• MDR Text Key: 160264042
• Report Number: 9612030-2019-02295
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 10884521007697
• UDI-Public: 10884521007697
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2019
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/02/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1