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

Model Number C6001

Device Problems Tear, Rip or Hole in Device Packaging (2385); Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/28/2023

Event Type  malfunction  

Event 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.

Manufacturer Narrative

The event device is anticipated to return.A follow-up report will be provided upon completion of the investigation.

Event 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.

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
• Type of Device: 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
• MDR Text Key: 326390011
• Report Number: 2027111-2023-00663
• Device Sequence Number: 1
• Product Code: FHF
• UDI-Device Identifier: 00607915116989
• UDI-Public: (01)00607915116989(17)260316(30)01(10)1483207
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: K003443
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• 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
• Initial Date Manufacturer Received: 09/28/2023
• Initial Date FDA Received: 10/24/2023
• Supplement Dates Manufacturer Received: 09/28/2023
• Supplement Dates FDA Received: 12/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/17/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1