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

Model Number	C6001
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit is anticipated to return to applied medical for evaluation.A follow-up report will be provided upon completion of the investigation.
Event or Problem Description
Name of procedure being performed: na.Detailed description of event: when the sterile medical device was opened (suction irrigation set), we saw a hair that was half interior half exterior of the sterile medical device.Material not used.Additional information received by email from applied medical representative on 11-feb-2022: i didn¿t manage to reach the person in charge of the file.Normally, the defective device is sent back to amersfoort today.Patient status: na (no patient involvement).Type of intervention: material not used.
Event or Problem Description
Name of procedure being performed: na.Detailed description of event: when the sterile medical device was opened (suction irrigation set), we saw a hair that was half interior half exterior of the sterile medical device.Material not used.Additional information received by email from applied medical representative on 11feb22 i didn¿t manage to reach the person in charge of the file.Normally, the defective device is sent back to amersfoort today.Patient status: na (no patient involvement).Type of intervention: material not used.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection noted a hair taped to the open packaging of the unit, confirming the complainant¿s experience of hair.Based on the condition of the returned unit and the description of the event, it is possible the hair originated from an operator during the manufacturing process.It is also possible the hair entered the pouch after it was opened at the user facility.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: aaron fulcher ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497135765
• MDR Report Key: 13564942
• Report Number: 2027111-2022-00391
• Device Sequence Number: 13950474
• Product Code: FHF
• UDI-Device Identifier: 00607915116989
• UDI-Public: (01)00607915116989(17)240830(30)01(10)1427896
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2022

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: 08/30/2024
• Device Model Number: C6001
• Device Catalogue Number: 101471627
• Device Lot Number: 1427896
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 01/26/2022
• Supplement Date Received by Manufacturer: 01/26/2022
• Initial Report FDA Received Date: 02/18/2022
• Supplement Report FDA Received Date: 05/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/31/2021
• 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