MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CTS22, 12X100 KII SLEEVE ZTHR 12/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	CTS22
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	07/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit is not being returned to applied medical for evaluation, but lot number is provided.A follow-up report will be provided upon completion of the investigation.
Event or Problem Description
Name of procedure being performed: na (during service).Detailed description of event: during the customer internal labeling process, in a cts22 closed box lot number 1521725, invoice (b)(4), was detected a pouch contaminated with a hair.The whole box has been segregated for integrity reasons.By customer process, they ask to pick up the whole box with a credit memo on hand.Patient status: na (no patient involvement).Type of intervention: na (no patient involvement).
Event or Problem Description
Name of procedure being performed: na (during service).Detailed description of event: during the customer internal labeling process, in a cts22 closed box lot number 1521725, invoice 9300135972, was detected a pouch contaminated with a hair.The whole box has been segregated for integrity reasons.By customer process, they ask to pick up the whole box with a credit memo on hand.Patient stauts: na (no patient involvement).Type of intervention: na (no patient involvement).
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.The hair was observed to be partially within the heat seal of the pouch.Testing was performed on the event unit, which confirmed the sterile barrier remained intact.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.Applied medical has performed a historical trend analysis and a review of production records and no relevant documentation was found.

• Brand Name: CTS22, 12X100 KII SLEEVE ZTHR 12/BX
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• 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: 19925024
• Report Number: 2027111-2024-00777
• Device Sequence Number: 2846819
• Product Code: GCJ
• UDI-Device Identifier: 00607915123734
• UDI-Public: (01)00607915123734(17)270426(30)01(10)1521725
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K060096
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2024

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: Lay User/Patient
• Device Model Number: CTS22
• Device Catalogue Number: 101244801
• Device Lot Number: 1521725
• 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: 07/22/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/06/2024
• Supplement Report FDA Received Date: 10/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/26/2024
• 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