MAUDE Adverse Event Report: MEDICAL COMPONENTS, INC. 12F CATHETER SET W/CUFF; SILICONE TESIO

Model Number CMD755

Device Problem Break (1069)

Patient Problems Respiratory Distress (2045); Device Embedded In Tissue or Plaque (3165)

Event Type  Injury  

Manufacturer Narrative

An investigation has been initiated.We are currently waiting for additional information and the return of the sample device for evaluation.When the investigation is completed a supplemental report will be submitted.

Event Description

During the insertion procedure, the sheath tubing separated from the hub.

Manufacturer Narrative

Supplier corrective action request was issued to the contract manufacturer for a root cause analysis investigation.

• Brand Name: 12F CATHETER SET W/CUFF
• Type of Device: SILICONE TESIO
• Manufacturer (Section D): MEDICAL COMPONENTS, INC.; 1499 delp drive; harleysville PA 19438
• MDR Report Key: 9439958
• MDR Text Key: 169913824
• Report Number: 2518902-2019-00078
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: 00884908005530
• UDI-Public: 884908005530
• Combination Product (y/n): N
• PMA/PMN Number: K981125
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 12/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 04/30/2023
• Device Model Number: CMD755
• Device Catalogue Number: CMD755
• Device Lot Number: MKBT450
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention