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 Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/17/2023

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 picc line was inserted (b)(6)2023 @ approximately 1600, placement was check and iv solutions were hung right away and the infusion was started.Of note, minimal manipulation and gentle tightening of the connecting hub was done by myself, the inserter.The next day, the bedside nurse noted fluid under the picc line dressing, she suspected the picc was leaking and called the medical team to assess the picc.The medical team noted the hub on the picc line was cracked, thus an end over end picc line replacement was completed and the cracked picc was removed and a new picc has remained in situ.This is a very fragile extremely low gestational age (less than 24 hours of age) infant who cannot tolerate prolonged handling and is at risk for ivh and temperature instability with any invasive procedures.So, he was not directly harmed at the time of picc insertion or picc replacement however, long-term implications of an extra procedure cannot be ruled out.

Event Description

The picc line was inserted (b)(6) 2023 @ approximately 1600, placement was check and iv solutions were hung right away and the infusion was started.Of note, minimal manipulation and gentle tightening of the connecting hub was done by myself, the inserter.The next day, the bedside nurse noted fluid under the picc line dressing, she suspected the picc was leaking and called the medical team to assess the picc.The medical team noted the hub on the picc line was cracked, thus an end over end picc line replacement was completed and the cracked picc was removed and a new picc has remained in situ.This is a very fragile extremely low gestational age (less than 24 hours of age) infant who cannot tolerate prolonged handling and is at risk for ivh and temperature instability with any invasive procedures.So, he was not directly harmed at the time of picc insertion or picc replacement however, long-term implications of an extra procedure cannot be ruled out.

Manufacturer Narrative

A review of the dhr and inspection records was conducted, and no similar concerns were found.One opened catheter was returned for review.Visual inspection confirmed a crack in the luer that would result in leakage.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: 16281475
• MDR Text Key: 309077520
• Report Number: 0001625425-2023-00956
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 03/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2023
• 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: 11438264
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/24/2022
• 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