MAUDE Adverse Event Report: MERIT MEDICAL SINGAPORE CATHETERS.CAREFLOW; CATHETER, INTRAVASCULAR, THERAPEUTIC

Catalog Number 681725/B

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

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

Event Date 02/14/2024

Event Type  Injury  

Event Description

The account alleges that during and central venous catheter implant procedure, the access wire became stuck within the patient and could not be removed.A surgeon was consulted, and the decision was made to surgically extract the access wire from the patient.No additional patient consequences to report.

Manufacturer Narrative

The suspect device is expected to return for evaluation.A supplemental report will be submitted once the evaluation is complete.

Manufacturer Narrative

The suspect medical device has been returned for evaluation.The device was visually and microscopically investigated.The complaint is confirmed.The root cause could not be determined however, it is likely that significant force was applied to the device during clinical use.The device history record was reviewed, and no exception documents were identified.A search of the complaint database was performed and no similar complaints for this lot number were identified.

• Brand Name: CATHETERS.CAREFLOW
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC
• Manufacturer (Section D): MERIT MEDICAL SINGAPORE; 198 yishun avenue 7; yishun, 76892 6; SN 768926
• Manufacturer (Section G): MERIT MEDICAL SINGAPORE; 198 yishun avenue 7; yishun, 76892 6; SN 768926
• Manufacturer Contact: bryson heaton bsn.rn ; 1600 merit pkwy; south jordan, UT 84095 ; 8012531600
• MDR Report Key: 18797424
• MDR Text Key: 336441099
• Report Number: 8020616-2024-00006
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K033500
• 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: 02/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: 681725/B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/14/2024
• Initial Date FDA Received: 02/28/2024
• Supplement Dates Manufacturer Received: 03/18/2024
• Supplement Dates FDA Received: 03/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ACCESS NEEDLE
• Patient Outcome(s): Required Intervention; Hospitalization