MAUDE Adverse Event Report: CARDINAL HEALTH, INC. REPLOGLE SUCTION CATHETER; CATHETERS, SUCTION, TRACHEOBRONCHIAL

Model Number 8888256529

Device Problems Fracture (1260); Improper Flow or Infusion (2954)

Patient Problem Insufficient Information (4580)

Event Date 09/13/2021

Event Type  malfunction  

Event Description

Patient had an 8 fr replogle decompression tube placed.Next day, tube was not draining/bubbling, rn (registered nurse) tried to troubleshoot and decided to remove the tube and replace with new tube.Upon removal of old tube, end of tube noted to be fractured and small piece of the plastic is missing.Uncertain if tube came this way or if tube fractured in patient.Manufacturer response for argyle replogle suction catheter, covidien (per site reporter): pending evaluation of device.

• Brand Name: REPLOGLE SUCTION CATHETER
• Type of Device: CATHETERS, SUCTION, TRACHEOBRONCHIAL
• Manufacturer (Section D): CARDINAL HEALTH, INC.; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 12561393
• MDR Text Key: 274261054
• Report Number: 12561393
• Device Sequence Number: 1
• Product Code: BSY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 09/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 8888256529
• Device Catalogue Number: 8888256529
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2021
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/16/2021
• Event Location: Hospital
• Date Report to Manufacturer: 10/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 6 DA