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

Model Number 384539

Device Problem Device-Device Incompatibility (2919)

Patient Problem Insufficient Information (4580)

Event Date 06/14/2022

Event Type  malfunction  

Manufacturer Narrative

He 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

Picc placed (b)(6) 2022: date of event 6/14/2022 - ¿the one is a little different the hub is not cracked.However, the entire hub disconnected from actual line.¿ ¿potential for infection r/t faulty line¿ a new piv and picc was placed to complete prescribed therapy.

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

Picc placed (b)(6) 2022.Date of event 6/14/2022 - ¿the one is a little different the hub is not cracked.However, the entire hub disconnected from actual line.¿ ¿potential for infection r/t faulty line¿.A new piv and picc was placed to complete prescribed therapy.

Event Description

Picc placed (b)(6) 2022 date of event (b)(6)2022 - ¿the one is a little different the hub is not cracked.However, the entire hub disconnected from actual line.¿ ¿potential for infection r/t faulty line¿ a new piv and picc was placed to complete prescribed therapy.

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 signs of use and confirmed that the luer was detached from the catheter tubing just above the strain relief.The breakage site was inspected under magnification and the edges of the tubing were jagged as though a tensile force had been applied to the catheter.The event description from the customer stated that the catheter had been indwelling for ten days.Possibly, the breakage was due to patient movement or manipulation of the catheter.There have been no other complaints regarding this issue with this lot number.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 issues of this nature in the future.

• 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: 14834123
• MDR Text Key: 295324112
• Report Number: 0001625425-2022-01034
• Device Sequence Number: 1
• Product Code: FOZ
• 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: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 08/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 384539
• Device Catalogue Number: 384539
• Device Lot Number: 11401159
• 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: 06/17/2022
• 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): Other