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 05/08/2023

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

Indication for dressing change ¿ was non-occlusive.Picc placed in nicu on 5/4.5/8 the bedside rn found a crack in the hard plastic part of the lumen with fluid leaking out of the site.The line was pulled and i placed another 1.9 fr silicone argon picc(without stiffening wire) in the patient at another site.

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 (b)(4) 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.

Event Description

Indication for dressing change ¿ was non-occlusive.Picc placed in nicu on (b)(6).(b)(6) the bedside rn found a crack in the hard plastic part of the lumen with fluid leaking out of the site.The line was pulled and i placed another 1.9 fr silicone argon picc(without stiffening wire) in the patient at another site.

• 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: 17079577
• MDR Text Key: 316693930
• Report Number: 0001625425-2023-01095
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 07/11/2023

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: 11445820
• 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: 05/24/2023
• Initial Date FDA Received: 06/07/2023
• Supplement Dates Manufacturer Received: 05/24/2023
• Supplement Dates FDA Received: 07/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/17/2022
• 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