MAUDE Adverse Event Report: ARGON MEDICAL DEVICES L-CATH PICC D/L 18GA (3.5F) 1.20MM X 60CM

Model Number	384467
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	12/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Sample is unavailable for evaluation.If additional information is provided in the future, a follow-up report will be submitted.
Event or Problem Description
Defect in blue lumen of double lumen picc led to infusion issues and leaking.Tubing appears to be migrating away from the cap.Photo available.The picc was removed from patient due to defect and bloodstream infection.Patient started on iv antibiotics.
Event or Problem Description
Defect in blue lumen of double lumen picc led to infusion issues and leaking.Tubing appears to be migrating away from the cap.Photo available.The picc was removed from patient due to defect and bloodstream infection.Patient started on iv antibiotics.
Additional Manufacturer Narrative
A review of the dhr and inspection records was conducted, and no similar concerns were found.According to the product experience report, there was no sample available to return for review.However, an image was provided that confirmed the blue tubing had migrated away from the luer hub.Without the sample to review, a definite root cause for the migration of the blue tubing could not be established with confidence.Based on the image alone, it could not be determined if the bushing was seated properly or if adhesive was applied or if the strain relief was the correct length and had been inserted correctly.There have been no other complaints regarding this issue with this part number or lot number, so this complaint has been deemed to be an isolated event.Since the reported issue was most likely an isolated event and a definite root cause could not be established based on the provided image alone, 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 D/L 18GA (3.5F) 1.20MM X 60CM
• Common Device Name: 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: 13333771
• Report Number: 0001625425-2022-00936
• Device Sequence Number: 4090456
• Product Code: LJS
• UDI-Device Identifier: 00886333209866
• UDI-Public: 00886333209866
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K091670
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/16/2023
• Device Model Number: 384467
• Device Catalogue Number: 384467
• Device Lot Number: 11314505
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2022
• Supplement Date Received by Manufacturer: 01/21/2022
• Initial Report FDA Received Date: 01/24/2022
• Supplement Report FDA Received Date: 02/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown