MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CA500, EPIX UNIVERSAL CLIP APPLIER 3/BX; INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Model Number CA500

Device Problem Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/12/2021

Event Type  malfunction  

Manufacturer Narrative

The event unit returned to applied medical for evaluation.A follow-up report will be provided upon completion of the investigation.

Event Description

Name of procedure being performed: na (incoming inspection).Detailed description of event: hospital staff found a hole in ca500 packaging during incoming inspection.The hole was confirmed by shining a light through packaging.Product is available for return.Patient status: na (no patient involvement).Type of intervention: na (incoming inspection).

Manufacturer Narrative

The event unit was returned to applied medical for evaluation.Visual inspection confirmed the complainant¿s experience of a hole in the packaging.Based on the condition of the returned unit, it is possible that the hole in the packaging was caused by contact with a sharp object during manufacturing or 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 Description

Name of procedure being performed: na (incoming inspection).Detailed description of event: hospital staff found a hole in ca500 packaging during incoming inspection.The hole was confirmed by shining a light through packaging.Product is available for return.Patient status: na (no patient involvement).Type of intervention: na (incoming inspection).

• Brand Name: CA500, EPIX UNIVERSAL CLIP APPLIER 3/BX
• Type of Device: INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
• 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: 12979594
• MDR Text Key: 285469789
• Report Number: 2027111-2021-00771
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 00607915125318
• UDI-Public: (01)00607915125318(17)230917(30)01(10)1395951
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K011236
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/08/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 09/17/2023
• Device Model Number: CA500
• Device Catalogue Number: 101471777
• Device Lot Number: 1395951
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/12/2021
• Initial Date FDA Received: 12/10/2021
• Supplement Dates Manufacturer Received: 11/12/2021
• Supplement Dates FDA Received: 03/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/17/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1