MAUDE Adverse Event Report: ARGON MEDICAL DEVICES L-CATH PICC S/L (BASIC KIT 28GA (1.2F) X 25CM 1 LUMEN)

Model Number 384516

Device Problem Crack (1135)

Patient Problem Pain (1994)

Event Date 01/31/2023

Event Type  malfunction  

Event Description

During infusion, bedside rn noted hub cracked on picc.Associated pain and new line placed.

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.

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.The analyst removed the tape from the catheter hub and confirmed a crack in the hub 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.

Event Description

During infusion, bedside rn noted hub cracked on picc.Associated pain and new line placed.

• Brand Name: L-CATH PICC S/L (BASIC KIT 28GA (1.2F) X 25CM 1 LUMEN)
• 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: 16281624
• MDR Text Key: 308860514
• Report Number: 0001625425-2023-00961
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00886333209910
• UDI-Public: 00886333209910
• 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: User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/22/2023

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: 384516
• Device Catalogue Number: 384516
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/31/2023
• Initial Date FDA Received: 02/01/2023
• Supplement Dates Manufacturer Received: 01/31/2023
• Supplement Dates FDA Received: 03/22/2023
• 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): Required Intervention; Other