MAUDE Adverse Event Report: ARGON MEDICAL DEVICES L-CATH PICC D/L 18GA (3.5F) 1.20MM X 60CM

Model Number 384467

Device Problems Fluid/Blood Leak (1250); Material Puncture/Hole (1504)

Patient Problem Insufficient Information (4580)

Event Date 03/12/2022

Event Type  malfunction  

Manufacturer Narrative

The sample is indicated as returned.As of the date of this report, the sample has not been evaluated.A follow-up report will be provided once the device has been reviewed.

Event Description

Clinician noticed leaking and discovered a hole in the line below hub.

Manufacturer Narrative

A review of the dhr and inspection records was conducted, and no similar concerns were found.12 sealed samples were returned for review.All of the samples were opened by the analyst and tested with a water filled syringe and no leakage was observed.The affected sample was not returned for review.Therefore, this complaint could not be confirmed.Since the reported issue could not be duplicated with the returned samples, no further evaluation was conducted and no corrective action was taken.

Event Description

Clinician noticed leaking and discovered a hole in the line below hub.

• Brand Name: L-CATH PICC D/L 18GA (3.5F) 1.20MM X 60CM
• Type of Device: L-CATH PICC
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek rd; athens TX 75751
• Manufacturer Contact: elnaz rahman ; 1445 flat creek rd; athens, TX 75751 ; 9036759321
• MDR Report Key: 14116644
• MDR Text Key: 295900182
• Report Number: 0001625425-2022-00979
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00886333209866
• UDI-Public: 00886333209866
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091670
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 05/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 384467
• Device Catalogue Number: 384467
• Device Lot Number: 11388868
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2022
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/01/2022
• Initial Date FDA Received: 04/14/2022
• Supplement Dates Manufacturer Received: 04/01/2022
• Supplement Dates FDA Received: 05/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other