MAUDE Adverse Event Report: ARGON MEDICAL DEVICES L-CATH PICC S/L 26GA (1.9F) 0.60MM X 30CM

Model Number 384539

Device Problem Crack (1135)

Patient Problem Insufficient Information (4580)

Event Date 05/18/2023

Event Type  malfunction  

Event Description

The argon picc was successfully inserted (b)(6) 2023 at 1400h, in an infant on day 3 of life.Site was the left antecubital.Tpn, smof, fentanyl and heparin infusions were started.Day 5 of life, (b)(6) 2023 picc was noted to be leaking at 1700h.Central line was removed.The hub was noted to be cracked.On (b)(6) 2023 at 0400h, the same picc was inserted into a scalp vessel (right side) on this same infant, who required central venous access.The picc was noted to be leaking by 1700h.It was removed.One of these 2 piccs (identical lot number) was saved in a biohazard bag for the company to inspect the defect.

Manufacturer Narrative

Sample is not available for return.The event is getting investigated.A follow-up report will be submitted upon investigation conclusion.

Event Description

The argon picc was successfully inserted (b)(6) 2023 at 1400h, in an infant on day 3 of life.Site was the left antecubital.Tpn, smof, fentanyl and heparin infusions were started.Day 5 of life,(b)(6) 2023 picc was noted to be leaking at 1700h.Central line was removed.The hub was noted to be cracked.On (b)(6) 2023 at 0400h, the same picc was inserted into a scalp vessel (right side) on this same infant, who required central venous access.The picc was noted to be leaking by 1700h.It was removed.One of these 2 piccs (identical lot number) was saved in a biohazard bag for the company to inspect the defect.

Manufacturer Narrative

A review of the dhr and inspection records was conducted, and no similar concerns were found.According to the customer, there was no sample available for review.However, based on the number of complaints regarding this issue with this lot number, this complaint will be confirmed for the reported issue.Several complaints for this part number have previously been received regarding a cracked hub resulting in leakage, and capa 2021-039 was initiated to address this issue.The capa is currently in the implementation phase and will evaluate the corrective action implementation for effectiveness to prevent a recurrence of this issue.

• Brand Name: L-CATH PICC S/L 26GA (1.9F) 0.60MM X 30CM
• Type of Device: L-CATH 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: 17002817
• MDR Text Key: 316009229
• Report Number: 0001625425-2023-01064
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00886333209934
• UDI-Public: 00886333209934
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091670
• 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: 07/14/2023

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 Model Number: 384539
• Device Catalogue Number: 384539
• Device Lot Number: 11440451
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/11/2023
• Initial Date FDA Received: 05/25/2023
• Supplement Dates Manufacturer Received: 05/11/2023
• Supplement Dates FDA Received: 07/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/08/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention