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

Model Number 384232

Device Problem Leak/Splash (1354)

Patient Problem Skin Discoloration (2074)

Event Date 04/02/2022

Event Type  malfunction  

Event Description

¿i have a lot with an expiration date of 10/8/2024 on (b)(6) 2022 that had a leak in the catheter.The baby it was in developed a white spot.¿.

Manufacturer Narrative

Sample is unavailable for evaluation.If additional information is provided in the future, a follow-up report will be submitted.

Event Description

¿i have a lot with an expiration date of 10/8/2024 on 4/2/2022 that had a leak in the catheter.The baby it was in developed a white spot.¿.

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 on the catheter tubing.Upon closer observation under magnification, a small pin hole 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 came in contact with a sharp instrument.Per the event description from the customer, the hole in the catheter was observed after removing the catheter.It was not stated how long the catheter had been in place when the white spot on the baby's leg appeared.There have been no other complaints regarding this issue with this lot number.Since the reported issue was most likely related to the user environment and not a manufacturing error, no corrective action will be taken.

• 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: 14139599
• MDR Text Key: 295490483
• Report Number: 0001625425-2022-00984
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 384232
• Device Catalogue Number: 384232
• Device Lot Number: 11389251
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/07/2022
• 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