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 Problems Crack (1135); Fluid/Blood Leak (1250); Flushing Problem (1252)

Patient Problem Insufficient Information (4580)

Event Date 09/03/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Picc placed in neonate.Once inserted, the physician attempted to flush the picc to lock it before xray.The rigid y piece was leaking and noted to be cracked at that time.It was removed and our clave was added.The physician was unable to flush the picc even after manipulation of the line.The picc was removed and multiple subsequent attempts were unsuccessful.

• 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
• MDR Report Key: 10555450
• MDR Text Key: 208314915
• Report Number: 1625425-2020-00527
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 09/18/2020

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: 09/06/2022
• Device Model Number: 28 GA (1.2F) X 25CM
• Device Catalogue Number: 384539
• Device Lot Number: 11274855
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/18/2020
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1