MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES C8303, L ALEXIS WND PROT/RET 5/BX; RING (WOUND PROTECTOR), DRAPE RETENTION, INTERNAL

Model Number	C8303
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	09/09/2021
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: [name] incoming inspection po#(b)(4).We would like to inform you that some of the products didn't pass our receiving inspection.There is a item require cer in this report.Particulate: hair, bug - c8303 lot# 1424309 (1 ea).Additional information received via email 01nov2021 from [name] regulatory affairs and quality assurance: it was reported that there was only one bug found.No report of hair in packaging.Patient status: na (no patient involvement).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 a bug inside the sterile unopened pouch.Based on the condition of the returned unit and the description of the event, the bug was most likely located inside a clear film roll used for packaging and was not detected during the manufacturing process.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.
Event or Problem Description
Name of procedure being performed.Na (incoming inspection).Detailed description of event: [name] incoming inspection (b)(4).We would like to inform you that some of the products didn't pass our receiving inspection.Please find attached spreadsheet.There is a item require cer in this report.Particulate: hair, bug - c8303 lot# 1424309 (1 ea).Additional information received via email 01nov2021 from [name] regulatory affairs and quality assurance: it was reported that there was only one bug found.No report of hair in packaging.Patient status: na (no patient involvement).Type of intervention: na (incoming inspection).

• Brand Name: C8303, L ALEXIS WND PROT/RET 5/BX
• Common Device Name: RING (WOUND PROTECTOR), DRAPE RETENTION, INTERNAL
• 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: 12865965
• Report Number: 2027111-2021-00738
• Device Sequence Number: 4571076
• Product Code: KGW
• UDI-Device Identifier: 00607915117221
• UDI-Public: (01)00607915117221(17)240802(30)01(10)1424309
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/11/2022

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: Other
• Device Expiration Date: 08/02/2024
• Device Model Number: C8303
• Device Catalogue Number: 101355901
• Device Lot Number: 1424309
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/27/2021
• Supplement Date Received by Manufacturer: 10/27/2021
• Initial Report FDA Received Date: 11/23/2021
• Supplement Report FDA Received Date: 01/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/03/2021
• 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