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

Model Number 384539

Device Problems Difficult to Flush (1251); Blocked Connection (2888); Physical Resistance/Sticking (4012)

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

Event Date 09/14/2023

Event Type  Injury  

Event Description

¿on (b)(6) 2023 the patient was ordered a picc.The picc was placed successfully in the right saphenous vein, positive blood return noted, confirmed by cxr, easily flushable.While attempting to remove the stylet, the catheter began to bunch up near the hub, stylet was also very difficult to remove.After removal, the catheter could not be flushed, no blood return.The picc was removed and a second picc was placed in the left lower saphenous vein.The line was prepped and flushed without difficulty.Upon insertion, blood return noted, easily flushable, cxr confirmed placement.Attempts to remove the stylet were very difficult with collection of the catheter at the hub.Catheter could not be flushed, no blood return.The picc was removed by attending provider with great difficulty, catheter could not be flushed.Reference: mw5145880.¿.

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

The sample is indicated as returned.As of the date of this report, the sample has not been evaluated.A follow-up report will be provided once the device has been reviewed.

Event Description

¿on (b)(6) 2023 the patient was ordered a picc.The picc was placed successfully in the right saphenous vein, positive blood return noted, confirmed by cxr, easily flushable.While attempting to remove the stylet, the catheter began to bunch up near the hub, stylet was also very difficult to remove.After removal, the catheter could not be flushed, no blood return.The picc was removed and a second picc was placed in the left lower saphenous vein.The line was prepped and flushed without difficulty.Upon insertion, blood return noted, easily flushable, cxr confirmed placement.Attempts to remove the stylet were very difficult with collection of the catheter at the hub.Catheter could not be flushed, no blood return.The picc was removed by attending provider with great difficulty, catheter could not be flushed.Reference: mw5145880.¿.

Event Description

"on (b)(6) 2023, the patient was ordered a picc.The picc was placed successfully in the right saphenous vein, positive blood return noted, confirmed by cxr, easily flushable.While attempting to remove the stylet, the catheter began to bunch up near the hub, stylet was also very difficult to remove.After removal, the catheter could not be flushed, no blood return.The picc was removed and a second picc was placed in the left lower saphenous vein.The line was prepped and flushed without difficulty.Upon insertion, blood return noted, easily flushable, cxr confirmed placement.Attempts to remove the stylet were very difficult with collection of the catheter at the hub.Catheter could not be flushed, no blood return.The picc was removed by attending provider with great difficulty, catheter could not be flushed.Reference: mw5145880.".

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.Visual inspection found the stylet was removed from the catheter.Therefore, the reported issue of resistance could not be confirmed.The customer reported a second issue regarding not being able to flush the device once the stylet was removed.An attempt to flush the device with a colored water filled syringe failed, confirming the reported issue of an occlusion.The luer was soaked in alcohol overnight and flushing the catheter was successful.The most probable cause for the blockage preventing the flushing of the device after the removal of the stylet was most likely due to bodily fluids inside the catheter.Since the reported issue was most likely related to the user environment and not a manufacturing error, no corrective action will be taken at this time.Argon will continue to monitor for reoccurrences.

• Brand Name: L-CATH PICC S/L 26GA (1.9F) 0.60MM X 30CM
• 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: 17914249
• MDR Text Key: 325412992
• Report Number: 0001625425-2023-01223
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00886333209934
• UDI-Public: 00886333209934
• 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: Other,Health Professional,User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup,Followup
• Report Date: 01/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 384539
• Device Lot Number: 11454702
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/13/2023
• 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; Required Intervention