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

Model Number 384466

Device Problems Crack (1135); Difficult to Flush (1251); Component Missing (2306); Device Dislodged or Dislocated (2923)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/18/2021

Event Type  malfunction  

Manufacturer Narrative

The sample was returned for evaluation.A follow-up report will be submitted once the investigation has been completed.

Event Description

2.6fr argon dl picc placed at (b)(6) on (b)(6) 2021 at 1808 in left brachial vein with 0.5 extremal length on (b)(6) 2021 at 1000 rn noted that red lumen was difficult to flush and requested picc rn assess picc rn found crack found in red hub where needless connector attaches picc removed and iv therapy continued with a piv.Note: patient readmitted to our facility on (b)(6) 2021.Slide clamps were missing from both lumens and extension sets were present on both lumens.Extension sets removed on (b)(6) 2021 due to dislocation noted by picc rn and replaced with new extension sets due to no slide clamps being present.

Manufacturer Narrative

A review of the returned catheter found a cracked hub which would result in leakage, confirming the complaint.Capa c-2020-016 was previously initiated to address the problem, however, the corrective actions implemented failed to mitigate the failure.The root cause investigation has been re-opened with a new capa c-2021-039.The capa will also capture the initiative to improve the product design.

Event Description

2.6fr argon dl picc placed at (b)(6) university health system (b)(6) on (b)(6) 2021 at 1808 in left brachial vein with 0.5 extremal length on (b)(6) 2021 at 1000 rn noted that red lumen was difficult to flush and requested picc rn assess picc rn found crack found in red hub where needless connector attaches picc removed and iv therapy continued with a piv.Note: patient readmitted to our facility on (b)(6) 2021.Slide clamps were missing from both lumens and extension sets were present on both lumens.Extension sets removed on (b)(6) 2021 due to dislocation noted by picc rn and replaced with new extension sets due to no slide clamps being present.

• 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
• MDR Report Key: 12481709
• MDR Text Key: 272868724
• Report Number: 0001625425-2021-01080
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• PMA/PMN Number: K091670
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 09/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 384466
• Device Catalogue Number: 384466
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other