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

Model Number 26GA (1.9F) X 30CM

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

Patient Problem Insufficient Information (4580)

Event Date 01/23/2023

Event Type  malfunction  

Event Description

Left peripherally inserted central line catheter (picc) requiring clave change.Plan was to remove clave under sterile conditions and replace with a t-connector instead of a clave to relieve weight on catheter, possibly contributing to cracked hubs.Clinical educator present to take pics for teaching purposes.Clave removed carefully and t-connector placed and flushed without incident, after line had bled back slightly.Dressing underneath was wet after changing the connector, requiring a dressing change.After assembling equipment for dressing change line had bled back.Attempted to flush, but the hub was cracked and the flush sprayed out of the hub.Appeared that the hub may have cracked during the clave change, and the initial flush was what had made the dressing wet --- the hub was maybe at a different angle so not as obvious.

• Brand Name: L-CATH¿ S/L PICC S/L
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): ARGON MEDICAL DEVICES, INC.; 1445 flat creek road; athens TX 75751
• MDR Report Key: 16371276
• MDR Text Key: 309492318
• Report Number: 16371276
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/30/2023

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 Model Number: 26GA (1.9F) X 30CM
• Device Catalogue Number: 384539
• Device Lot Number: 11441589
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/30/2023
• Event Location: Hospital
• Date Report to Manufacturer: 02/14/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/14/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 7 DA
• Patient Sex: Female
• Patient Weight: 1 KG