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 Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Edema (1820)

Event Date 11/07/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Large amount body wall edema, pulled picc 11/4 placed 28ga single lumen picc in rt basillic vein.

Manufacturer Narrative

H3 other text: placeholder.

Event Description

Follow up.

Event Description

Follow up.

Manufacturer Narrative

H3 other text: placeholder.

• Brand Name: L-CATH PICC SINGLE LUMEN 28GA (1.2F) X 25CM
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek rd; athens TX
• MDR Report Key: 11083270
• MDR Text Key: 224602091
• Report Number: 1625425-2020-00807
• 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,Followup
• Report Date: 12/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/11/2023
• Device Model Number: 28 GA (1.2F) X 25CM
• Device Catalogue Number: 384516
• Device Lot Number: 11309937
• Was Device Available for Evaluation?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other