MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CFB03, 5X100 KII SH BLD ADVFIX, 6/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	CFB03
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit returned 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 (incoming inspection).Detailed description of event: "a customer called regarding a shipment of sterile items.The problem item was opened and a hair was found on the product." additional information via telephone on (b)(6) 2022 from [name], supervisor of supply chain operations, [facility]: a hair found inside the sterile packaging.Model and lot number was provided.Patient status: na (incoming inspection).Type of intervention: na (incoming inspection).
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection confirmed the presence of hair inside the sterile unopened pouch.Based on the condition of the returned unit and the description of the event, the hair likely originated from an operator during the manufacturing process.
Event or Problem Description
Name of procedure being performed: na (incoming inspection).Detailed description of event: "a customer called regarding a shipment of sterile items.The problem item was opened and a hair was found on the product." additional information via telephone on 20jul2022 from [name], supervisor of supply chain operations, [facility]: a hair found inside the sterile packaging.Model and lot number was provided.Patient status: na (incoming inspection).Type of intervention: na (incoming inspection).

• Brand Name: CFB03, 5X100 KII SH BLD ADVFIX, 6/BX
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• 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: 15204714
• Report Number: 2027111-2022-00697
• Device Sequence Number: 14608179
• Product Code: GCJ
• UDI-Device Identifier: 00607915117627
• UDI-Public: (01)00607915117627(17)230316(30)01(10)1383765
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K083638
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/20/2022

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: 03/16/2023
• Device Model Number: CFB03
• Device Catalogue Number: 101221401
• Device Lot Number: 1383765
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2022
• 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: 07/15/2022
• Supplement Date Received by Manufacturer: 07/15/2022
• Initial Report FDA Received Date: 08/10/2022
• Supplement Report FDA Received Date: 09/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/16/2020
• 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
• Patient Sex: Unknown