MAUDE Adverse Event Report: ARGON MEDICAL DEVICES PAC TRAY/5 CATHETER INTRODUCER TRAY 8F

Model Number	497424
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	07/13/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Sample is unavailable for evaluation.Without such evident to review, the complaint cannot be confirmed.If additional information is provided in the future, a follow-up report will be submitted.
Event or Problem Description
The clear tube fell off from the white one-way valve and bleeding accrued.Fda safety report id.

• Brand Name: PAC TRAY/5 CATHETER INTRODUCER TRAY 8F
• Common Device Name: PAC TRAY
• 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: 15447024
• Report Number: 0001625425-2022-01097
• Device Sequence Number: 4729282
• Product Code: DRE
• UDI-Device Identifier: 00886333214440
• UDI-Public: 00886333214440
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K780126
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2023
• Device Model Number: 497424
• Device Catalogue Number: 497424
• Device Lot Number: 11416496
• 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: 09/09/2022
• Initial Report FDA Received Date: 09/19/2022
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown