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

Model Number	8888264945
Medical Device Problem Codes	Crack (1135); Suction Problem (2170)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/30/2019
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): COVIDIEN; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• MDR Report Key: 9126331
• Report Number: 9612030-2019-02295
• Device Sequence Number: 11397394
• Product Code: KNT
• UDI-Device Identifier: 10884521007697
• UDI-Public: 10884521007697
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/26/2019

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
• Operator of Device: No Information
• Device Model Number: 8888264945
• Device Catalogue Number: 8888264945
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/02/2019
• Initial Report FDA Received Date: 09/26/2019
• Patient Sequence Number: 1