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

Model Number 8888266130

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/08/2021

Event Type  malfunction  

Manufacturer Narrative

The complainant indicated that the device will not be returned for evaluation; 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.  as part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.  if additional information or the sample is received, the investigation will be reopened and responded to accordingly.

Event Description

Customer reports: the anti-reflux valve on patient oral gastric tube.The white end connected to oral gastric tube to clamp off system during transport to mri.On return from mri, when attempting to disconnect white end from oral gastric drain end white piece broke off from valve system and remained in oral gastric tube.Could not remove white end despite attempt to pry out of tube.Oral gastric tube removed.New nasogastric tube inserted.

• Brand Name: SALEM SUMP W/ ARV 16FR. 48IN
• Type of Device: TUBE, DOUBLE LUMEN FOR INTESTINAL DECOMPRESSION AND/OR INTUBATION
• Manufacturer (Section D): CARDINAL HEALTH; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• Manufacturer (Section G): CARDINAL HEALTH; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 12632007
• MDR Text Key: 276383444
• Report Number: 9612030-2021-03061
• Device Sequence Number: 1
• Product Code: FEG
• UDI-Device Identifier: 10884521004719
• UDI-Public: 10884521004719
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2021
• 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: 2117345564
• Date Manufacturer Received: 10/13/2021
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1