MAUDE Adverse Event Report: ARGON MEDICAL DEVICES L-CATH PICC S/L 20GA 3F X 60CM

Model Number	Z0384463AAL
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	11/30/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Picc line discovered leaking blood from connector between female and of picc line and luer lock connector from extension tubing.Discovered crack on female end of picc line.Date of insertion: (b)(6) 2023 (in situ 5 days) injury: undetermined amount of blood loss.Intervention: picc line removed resulting in loss of tpn infused and undetermined amount of blood loss from defective picc area.Iv insertion initiated.
Additional 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.
Additional Manufacturer Narrative
A review of the complaints database was conducted, and over the previous six months.There was one other complaint found related to this lot number for this failure mode and issue.A review of the dhr and inspection records was conducted, and no similar concerns were found.One opened catheter was returned for review.A crack in the luer (hub) was confirmed that would result in leakage.Several complaints for this part number have previously been received regarding a cracked hub resulting in leakage, and an internal investigation was initiated to address this issue.The investigation is currently in the effectiveness phase and will evaluate the corrective action implementation for effectiveness to prevent a recurrence of this issue.
Additional Manufacturer Narrative
Udi related data quality updates only.

• Brand Name: L-CATH PICC S/L 20GA 3F X 60CM
• Common Device Name: L-CATH PICC
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek rd; athens TX 75751
• Manufacturer Contact: kelly mayer ; 1445 flat creek rd; athens, TX 75751 ; 9036759321
• MDR Report Key: 18573283
• Report Number: 0001625425-2024-00925
• Device Sequence Number: 7853300
• Product Code: LJS
• UDI-Device Identifier: 00886333209828
• UDI-Public: (01)00886333209828(17)260208(10)11463628
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K091670
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/04/2024

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: 02/08/2026
• Device Model Number: Z0384463AAL
• Device Lot Number: 11463628
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2024
• Supplement Date Received by Manufacturer: 01/30/2024; 09/04/2024
• Initial Report FDA Received Date: 01/24/2024
• Supplement Report FDA Received Date: 02/28/2024; 09/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/08/2023
• 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
• Patient Sex: Unknown