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

Model Number 8888264960E

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

An investigation is currently underway.Upon completion, the results will be forwarded.

Event Description

The customer reported loss of tightness at the junction of the blue tube.Additional information received stated two consecutive probes showed liquid leakage at the junction of the blue and transparent tubes.

Manufacturer Narrative

Additional information: h4 device manufacturing date was added.The device history record (dhr) was reviewed showing no discrepancy.A sample analysis could not be performed because no photo or sample was available for evaluation.The complaint will be reopened if sample is received.The reported condition could not be confirmed.Based on the present information a root cause cannot be determined.The reported issue could not be confirmed to be related to the manufacturing process.No action plan is deemed required at this time.This complaint will be used for tracking and trending purposes.

• Brand Name: ENFIT SALEM SUMP PVC TUBE 16FR 48IN
• Type of Device: TUBE, DOUBLE LUMEN FOR INTESTINAL DECOMPRESSION AND/OR INTUBATION
• Manufacturer (Section D): CARDINAL HEALTH; 777 west street; mansfield MA 02048
• 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: 17510845
• MDR Text Key: 321105974
• Report Number: 9612030-2023-03787
• Device Sequence Number: 1
• Product Code: FEG
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 8888264960E
• Device Catalogue Number: 8888264960E
• Device Lot Number: 2305500464
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/04/2023
• Date Device Manufactured: 03/01/2023
• Type of Device Usage: A
• Patient Sequence Number: 1