MAUDE Adverse Event Report: MERIT MEDICAL SINGAPORE PTE. LTD. CAREFLOW CENTRAL VENOUS CATHETER

Catalog Number 681662

Device Problems Break (1069); Fracture (1260)

Patient Problems Obstruction/Occlusion (2422); Patient Problem/Medical Problem (2688)

Event Date 02/08/2018

Event Type  Injury  

Manufacturer Narrative

The suspect device is expected to return for evaluation. A follow up will be submitted when the evaluation is complete.

Event Description

The account alleged after insertion of the central venous catheter (cvc) it was discovered that it was not possible to draw blood and difficult to inject fluid. Upon inspection the hub was cracked. This was a pediatric patient with ileus in need of total parenteral nutrition (tpn). The patient was an in-patient who was taken back into the operating room later that night for additional anesthesia to place a new cvc. The physician administered the extra anesthesia because of the patient's current condition and age. No patient injury to report.

Manufacturer Narrative

The suspect device was returned for evaluation. The device was examined visually. The complaint is confirmed. The root cause could not be confirmed, however, it is likely that the hub was over-tightened during use. A review of the device history record was performed and no exception documents were found. A review of the complaint database was performed and no similar complaints for this lot number were found.

• Brand Name: CAREFLOW CENTRAL VENOUS CATHETER
• Type of Device: CENTRAL VENOUS CATHETER
• Manufacturer (Section D): MERIT MEDICAL SINGAPORE PTE. LTD.; 198 yishun ave. 7; singapore, sg-03 76892 6; SN 768926
• Manufacturer (Section G): MERIT MEDICAL SINGAPORE PTE. LTD.; 198 yishun ave. 7; singapore, sg-03 76892 6; SN 768926
• Manufacturer Contact: casey hughes, ms, cqe, csqp ; 1600 merit parkway; south jordan, UT 84095
• MDR Report Key: 7364325
• MDR Text Key: 103268655
• Report Number: 8020616-2018-00004
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K033500
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 03/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 03/01/2022
• Device Catalogue Number: 681662
• Device Lot Number: 705192
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 04/06/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/15/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 03/22/2018 Patient Sequence Number: 1