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

Model Number 384516

Device Problem Break (1069)

Patient Problems Laceration(s) (1946); Foreign Body In Patient (2687)

Event Date 05/11/2022

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

While inserting a picc line, the line fractured leaving approx.12 cm of line in infant.Chest/abdomen xr (including the left leg).Baby went through a surgery the following day ( incision on the leg) and had the broken catheter removed.No suspected severe long term adverse impact.The outside of this package kit has a product code:384516 (lot#11392849).Inside the kit: 28gauge l-cath picc polyurethane catheter: product #384540 (lot# 11389865).Splittable needle introducer: product#384061 (lot#11384333).

Manufacturer Narrative

A review of the dhr and inspection records was conducted for top and sub lot numbers, and no similar concerns were found.One catheter and one splittable needle were returned for review visual inspection confirmed breakage of the catheter tubing.Visual inspection confirmed signs of use as dried bodily fluids were found inside the hub of the splittable needle and on the catheter.The wings of the splittable needle were still intact and had not been broken apart as they are designed for use.The most probable cause for the reported issue was most likely due to an event within the user environment.Possibly the catheter was cut by something sharp.Or possibly a force was used on the catheter during the insertion as the ifu warns against.There have been no other complaints regarding this issue with this lot number.Since the reported issue was most likely related to an event within the user environment and not a manufacturing error, no corrective action will be taken.

Event Description

While inserting a picc line, the line fractured leaving approx.12 cm of line in infant.Chest/abdomen xr (including the left leg).Baby went through a surgery the following day ( incision on the leg) and had the broken catheter removed.No suspected severe long term adverse impact.The outside of this package kit has a product code:384516 (lot#11392849).Inside the kit: 28gauge l-cath picc polyurethane catheter: product #384540 (lot# 11389865).Splittable needle introducer: product#384061 (lot#11384333).

• Brand Name: L-CATH PICC S/L (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: 14547838
• MDR Text Key: 295491776
• Report Number: 0001625425-2022-01013
• 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: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 05/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2022
• 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
• Device Lot Number: 11392849
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/24/2022
• 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