MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES G-1200, 12MM SPRING CLIP S/S 15/BX; CLIP, VASCULAR

Model Number	G-1200
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/02/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event device is anticipated to return.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: [distributor] incoming inspection po#am23-008.We would like to inform you that some of the products didn't pass our receiving inspection.Please find attached spreadsheet.This report has cer non-conformance items.G-1200 lot #1456821 (1 ea.) - poor sealing "dscn0173".Type of intervention: na (incoming inspection).Patient status: na (no patient involvement).
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection confirmed the complainant¿s experience of small scratches and holes on the mylar, the clear film of the pouch.Based on the condition of the returned unit, it is possible that the small scratches and holes on the mylar were caused due to improper handling of the unit.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: [distributor] incoming inspection po# (b)(4).We would like to inform you that some of the products didn't pass our receiving inspection.Please find attached spreadsheet.This report has cer non-conformance items.G-1200 lot #1456821 (1 ea.) - poor sealing "(b)(6)" additional information was received via email on 26jul2023 from [name], [distributor]: when asking for clarification on what was meant by "poor sealing", the distributor responded "film has small scratches and holes." type of intervention: na (incoming inspection).Patient status: na (no patient involvement).

• Brand Name: G-1200, 12MM SPRING CLIP S/S 15/BX
• Common Device Name: CLIP, VASCULAR
• 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: 17481599
• Report Number: 2027111-2023-00548
• Device Sequence Number: 17928247
• Product Code: DSS
• UDI-Device Identifier: 00607915117887
• UDI-Public: (01)00607915117887(17)270816(30)01(10)1456821
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K883909
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/12/2024

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: Other
• Device Model Number: G-1200
• Device Catalogue Number: 101373101
• Device Lot Number: 1456821
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2023
• Supplement Date Received by Manufacturer: 07/14/2023
• Initial Report FDA Received Date: 08/08/2023
• Supplement Report FDA Received Date: 01/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/17/2022
• 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