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

Model Number 384539

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 10/12/2020

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned.A follow-up report will be submitted once the device has been returned and evaluated.

Event Description

Withdraw of guidewire wire broke apart luckily all was retrieved.

Manufacturer Narrative

One damaged/kinked stylet wire and stylet handle were returned for review.Visual inspection confirmed breakage of the stylet from the stylet handle.Based on the review of the returned sample, the damage to the wire that resulted in breakage was most likely caused by the application of excessive force to the wire during withdrawal.Thus the issue could be related to an event within the user environment.

Event Description

Withdraw of guidewire wire broke apart luckily all was retrieved.

• Brand Name: L-CATH PICC S/L 26GA (1.9F) 0.60MM X 30CM
• Type of Device: L-CATH PICC
• MDR Report Key: 12603035
• MDR Text Key: 277113097
• Report Number: 0001625425-2021-01091
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00886333209934
• UDI-Public: 00886333209934
• Combination Product (y/n): N
• PMA/PMN Number: K091670
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 11/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2022
• Device Model Number: 384539
• Device Catalogue Number: 384539
• Device Lot Number: 11281534
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/13/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other