MAUDE Adverse Event Report: ARGON MEDICAL DEVICES PICC POLYURETHANE SINGLE LUMEN, 28G (1.2FR) X 25CM; L-CATH PICC

Catalog Number 384540

Device Problem Fluid/Blood Leak (1250)

Patient Problems Cellulitis (1768); Phlebitis (2004)

Event Date 06/05/2020

Event Type  malfunction  

Manufacturer Narrative

The device used is indicated as available for evaluation.As of the date of this report, the sample has not yet been returned.A follow-up report will be provided once the sample has been received and reviewed.

Event Description

Significant catheter leakage (3 occurrences with the same patient and at least one other).Very rare problem, 3 different experienced inserters.Red track along the course of the vein, difficult withdrawal from the saphenous, oedema in the limb.Different location in each case.Patient presented with probable superficial hardening/cellulites/phlebitis following dwell times of 11, 3 and 3 days.The inserting mds believe that the catheter is getting stuck in the splittable introducer needle, which affects permeability, and that breakage may occur.Total number of leaking catheters: 4; total number of needles: 6.

Event Description

Follow up.

Manufacturer Narrative

H3 other text : placeholder.

Event Description

Follow up.

• Brand Name: PICC POLYURETHANE SINGLE LUMEN, 28G (1.2FR) X 25CM
• Type of Device: L-CATH PICC
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek rd; athens TX
• MDR Report Key: 10391237
• MDR Text Key: 203475863
• Report Number: 1625425-2020-00474
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: K091670
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/11/2020

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/21/2023
• Device Catalogue Number: 384540
• Device Lot Number: 11297648
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/11/2020
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 08/28/2020; 10/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other