MAUDE Adverse Event Report: ARGON MEDICAL DEVICES L-CATH PICC SINGLE LUMEN 28GA (1.2F) X 25CM

Model Number 28 GA (1.2F) x 25cm

Device Problem Leak/Splash (1354)

Patient Problem Tissue Breakdown (2681)

Event Date 04/12/2020

Event Type  malfunction  

Manufacturer Narrative

Argon has made three requests for the return of the sample for evaluation.As of the date of this report, the sample has not been returned.Without such evidence, the complaint cannot be confirmed and the root cause cannot be determined.If additional information is received in the future, a follow-up report will be provided.

Event Description

At 1200 assessment picc line was noted to have tpn under the dressing and dressing was wet.Np was called to bedside and attempted to flush and replace extension set and unable due to leaking at hub of picc during flush.This picc was inserted on 3/21 and had required 10 dressing changes in the 22 days it was in place due to skin breakdown underneath and problems with dressing adhering to denuded skin.

• Brand Name: L-CATH PICC SINGLE LUMEN 28GA (1.2F) X 25CM
• Type of Device: L-CATH PICC
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek rd; athens TX
• Manufacturer Contact: gina liu ; 1445 flat creek rd, athens, tx 75751
• MDR Report Key: 10226875
• MDR Text Key: 197915000
• Report Number: 1625425-2020-00386
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00886333209910
• UDI-Public: 00886333209910
• 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
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 07/02/2020

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 Expiration Date: 01/14/2023
• Device Model Number: 28 GA (1.2F) x 25cm
• Device Catalogue Number: 384516
• Device Lot Number: 11291561
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/02/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1