MAUDE Adverse Event Report: ARGON MEDICAL DEVICES FIRST PICC S/L BASIC KIT 26GA (1.9F) X 50CM 1 LUMEN

Model Number	384221
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/30/2021
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
"newborn with picc catheter inserted on (b)(6) 2021, receiving continuous infusion of basal saline solution by infusion pump, observed leakage of saline solution in bed, catheter was washed and it was verified that it was punctured".
Additional 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 of the catheter found signs of use.Functional testing confirmed leakage along the silicone tubing above the oval disc.Under magnification, a slit was observed at the leakage site as though the product had been cut by a sharp instrument.No manufacturing error was observed.The most probable cause for the damage to the catheter that resulted in leakage was most likely related to an event within the user environment.Possibly the damage was the result of a sharp instrument inadvertently cutting the catheter.Since the reported issue was most likely related to the user environment and not a manufacturing error, no corrective action will be taken.
Event or Problem Description
"newborn with picc catheter inserted on (b)(6) 2021, receiving continuous infusion of basal saline solution by infusion pump, observed leakage of saline solution in bed, catheter was washed and it was verified that it was punctured".

• Brand Name: FIRST PICC S/L BASIC KIT 26GA (1.9F) X 50CM 1 LUMEN
• Common Device Name: 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: 12965673
• Report Number: 0001625425-2021-01206
• Device Sequence Number: 19996390
• Product Code: FOZ
• UDI-Device Identifier: 00886333209743
• UDI-Public: 00886333209743
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K972262
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 01/24/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2023
• Device Model Number: 384221
• Device Catalogue Number: 384221
• Device Lot Number: 11353870
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/26/2021
• Supplement Date Received by Manufacturer: 11/26/2021
• Initial Report FDA Received Date: 12/08/2021
• Supplement Report FDA Received Date: 01/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown