MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES C6001, 5MMX33CM PROBVALV DB, G2EB, 12B; SYSTEM, EVACUATOR, FLUID

Model Number	C6001
Medical Device Problem Codes	Tear, Rip or Hole in Device Packaging (2385); Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Name of procedure being performed: no information.Detailed description of event:  "hole/tear in packaging.Item was open onto sterile field without noticing that there was a hole/tear in the packaging, thus contaminating the sterile field and consumables".Another device was opened to complete the case.Product is available for return.Type of intervention: another device was opened to complete the case.Patient status: no patient injury.
Additional Manufacturer Narrative
The event device is anticipated to return.A follow-up report will be provided upon completion of the investigation.
Event or Problem Description
Name of procedure being performed: no information.Detailed description of event: "hole/tear in packaging.Item was open onto sterile field without noticing that there was a hole/tear in the packaging, thus contaminating the sterile field and consumables".Another device was opened to complete the case.Product is available for return.Type of intervention: open another pack.Patient status: no patient injury.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection confirmed the complainant¿s experience of a hole in the packaging.Based on the condition of the returned unit, it is possible that the hole in the packaging was caused due to improper handling of the unit.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.

• Brand Name: C6001, 5MMX33CM PROBVALV DB, G2EB, 12B
• Common Device Name: SYSTEM, EVACUATOR, FLUID
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• Manufacturer Contact: farah azmi ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497138710
• MDR Report Key: 17996357
• Report Number: 2027111-2023-00663
• Device Sequence Number: 20319660
• Product Code: FHF
• UDI-Device Identifier: 00607915116989
• UDI-Public: (01)00607915116989(17)260316(30)01(10)1483207
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K003443
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/01/2023

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: 03/16/2026
• Device Model Number: C6001
• Device Catalogue Number: 101475960
• Device Lot Number: 1483207
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/28/2023
• Supplement Date Received by Manufacturer: 09/28/2023
• Initial Report FDA Received Date: 10/24/2023
• Supplement Report FDA Received Date: 12/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/17/2023
• 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
• Patient Sex: Unknown