MAUDE Adverse Event Report: ARGON MEDICAL DEVICES FIRST PICC S/L 26GA (1.9F) 0.65MM X 50CM

Model Number 384232

Device Problems Fluid/Blood Leak (1250); Material Puncture/Hole (1504)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/26/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer said, ¿we had a picc line with multiple holes in the thicker part of the line proximal to the securement disc./the line was leaking and was removed from the patient.¿ the location of the holes is in between the disc and the connector.

Manufacturer Narrative

A review of the dhr and inspection records was conducted, and no similar concerns were found.One catheter was returned for review.Visual inspection did not find any damage to the catheter.The catheter was leak tested with a water filled syringe using red food coloring.Evidence of leakage was confirmed at the silicone extension just below the securement disc.Upon closer observation under magnification, a slit in the silicone was observed.The most probable root cause for the damage to the catheter was most likely related to an event within the user environment.Possibly the catheter was inadvertently cut with a sharp instrument.Since the reported issue was most likely related to the user environment and not a manufacturing error, no corrective action will be taken.

Event Description

The customer said, ¿we had a picc line with multiple holes in the thicker part of the line proximal to the securement disc./the line was leaking and was removed from the patient.¿ the location of the holes is in between the disc and the connector.

• Brand Name: FIRST PICC S/L 26GA (1.9F) 0.65MM X 50CM
• Type of Device: FIRST PICC
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek rd; athens TX 75751
• Manufacturer Contact: elnaz rahman ; 1445 flat creek rd; athens, TX 75751 ; 9036759321
• MDR Report Key: 13767486
• MDR Text Key: 291633466
• Report Number: 0001625425-2022-00960
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00886333209750
• UDI-Public: 00886333209750
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K972262
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/02/2022

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: 06/04/2024
• Device Model Number: 384232
• Device Catalogue Number: 384232
• Device Lot Number: 11371220
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/01/2022
• Initial Date FDA Received: 03/15/2022
• Supplement Dates Manufacturer Received: 03/01/2022
• Supplement Dates FDA Received: 05/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other