MAUDE Adverse Event Report: ARGON MEDICAL DEVICES L-CATH PICC D/L 20GA (2.6F) 0.90MM X 60CM

Model Number 384466

Device Problem Crack (1135)

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

Event Date 04/26/2023

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.Images were provided as well.A follow-up report will be provided once the device has been received and reviewed.

Event Description

Blue lumen hub cracked fluid leaking¿.¿(b)(6) 2023 18:15 pn bag changed ¿ needless connector changed without issue, labs drawn and line flushed with no leaking noted.(b)(6) 2023 21:25 line leaking crack noted in hub.¿ ¿date of insertion (b)(6) 2023¿.Was a new picc or piv placed for continuation of prescribed therapy ¿yes the catheter was exchanged for a new 2.6.

Event Description

Blue lumen hub cracked fluid leaking¿ ¿(b)(6)2023 18:15 pn bag changed ¿ needless connector changed without issue, labs drawn and line flushed with no leaking noted.4/25/23 21:25 line leaking crack noted in hub.¿ ¿date of insertion (b)(6)2023¿ was a new picc or piv placed for continuation of prescribed therapy ¿yes the catheter was exchanged for a new 2.6.

Manufacturer Narrative

A review of the dhr and inspection records was conducted, and no similar concerns were found.After three notifications, there has been no sample returned for review.However, images were provided that were consistent with the reported issue coupled with the multiple complaints against this part number and lot number.Therefore, this complaint will be confirmed for one device.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 D/L 20GA (2.6F) 0.90MM X 60CM
• 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: 16904798
• MDR Text Key: 314937313
• Report Number: 0001625425-2023-01054
• Device Sequence Number: 1
• Product Code: LJS
• 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: 08/29/2023

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: 384466
• Device Catalogue Number: 384466
• Device Lot Number: 11455368
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/26/2023
• Initial Date FDA Received: 05/10/2023
• Supplement Dates Manufacturer Received: 04/26/2023
• Supplement Dates FDA Received: 08/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/06/2023
• 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