MAUDE Adverse Event Report: MERIT MEDICAL SINGAPORE PTE LTD. CAREFLOW¿; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number 681649

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pneumothorax (2012)

Event Date 08/28/2007

Event Type  malfunction  

Event Description

A study alleges that on postoperative day 4, patient complained of chest pain and dyspnea after placement of a central venous catheter.Chest x-ray showed bilateral pneumothorax.Pneumothorax treated with bilateral thoracotomy tubes (20fr) for 4 days.

Manufacturer Narrative

The suspect device is not expected to return for evaluation.A follow up will be submitted when the evaluation is complete.

Manufacturer Narrative

The suspect device is not expected to return for evaluation.The complaint could not be confirmed.The root cause could not be determined.A review of the device history and complaint database could not be performed since the lot number was not provided.Should the device be returned at a later date, the investigation will be reopened.

• Brand Name: CAREFLOW¿
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): MERIT MEDICAL SINGAPORE PTE LTD.; 198 yishun ave 7; singapore, sgp 76892 6; SN 768926
• Manufacturer (Section G): MERIT MEDICAL SINGAPORE PTE LTD.; 198 yishun ave 7; singapore, sgp 76892 6; SN 768926
• Manufacturer Contact: bryson heaton ; 1600 merit parkway; south jordan, UT 84095 ; 8012084662
• MDR Report Key: 15638444
• MDR Text Key: 302068031
• Report Number: 8020616-2022-00098
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00886333616497
• UDI-Public: 00886333616497
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K033500
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 681649
• Device Catalogue Number: 681649/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Life Threatening