MAUDE Adverse Event Report: ARGON MEDICAL DEVICES INC. L-CATH PICC 26G; CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS

Lot Number 11439001

Device Problems Crack (1135); Leak/Splash (1354)

Patient Problem Insufficient Information (4580)

Event Date 09/01/2022

Event Type  malfunction  

Event Description

Midline inserted - leaking noted by staff and found that hub of catheter was cracked.We have had numerous reports of this same issue from different lot numbers between september 2022 and january 2023.Many times, the line has been in less than 24 hours before leaking is noted.Lots: 11439001, 11438264, 11413409, 11410069, 11419018.

• Brand Name: L-CATH PICC 26G
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): ARGON MEDICAL DEVICES INC.
• MDR Report Key: 16272843
• MDR Text Key: 308581621
• Report Number: MW5114590
• Device Sequence Number: 2
• Product Code: LJS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 01/27/2023
• 5 Devices were Involved in the Event: 1 2 3 4 5

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Lot Number: 11439001
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/30/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 3 DA
• Patient Ethnicity: Non Hispanic
• Patient Race: White