MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES C8323, XXS ALEXIS WND PROT/RET SHRT 5/BX; RING (WOUND PROTECTOR), DRAPE RETENTION, INTERNAL

Model Number	C8323
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Patient Involvement (2645)
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 investigation completion.
Event or Problem Description
Name of procedure being performed na (incoming inspection).Detailed description of event: medical leaders po#20-12app.Regarding to po#20-12app, we would like to report that the products did not pass our inspection.Torn packaging - c8323 lot# 1384885 (2 ea).Additional information received via email on 14sep2020 from [name]: the product did not pass the incoming inspection of po#20-12app because of torn packaging.Details are shown on the attached file.Patient status: na.Type of intervention: na.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Upon visual inspection, engineering confirmed that there was a hole in the tyvek of the pouch.Based on the condition of the returned unit, the hole in the pouch was caused by contact with an object, which likely occurred while the product was being handled.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] po#(b)(4).Regarding to po#(b)(4), we would like to report that the products did not pass our inspection as attached.Torn packaging - c8323, lot# 1384885 (2 ea).Additional information received via email on 14sep2020 from [name]: the product did not pass the incoming inspection of po#(b)(4) because of torn packaging.Details are shown on the attached file.Patient status: na.Type of intervention: na.

• Brand Name: C8323, XXS ALEXIS WND PROT/RET SHRT 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
• MDR Report Key: 10623837
• Report Number: 2027111-2020-00571
• Device Sequence Number: 16795569
• Product Code: KGW
• UDI-Device Identifier: 00607915132941
• UDI-Public: (01)00607915132941(17)230422(30)01(10)1384885
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/24/2020

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: No Information
• Device Expiration Date: 04/22/2023
• Device Model Number: C8323
• Device Catalogue Number: 101432601
• Device Lot Number: 1384885
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/08/2020
• Supplement Date Received by Manufacturer: 09/08/2020
• Initial Report FDA Received Date: 10/02/2020
• Supplement Report FDA Received Date: 11/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1