MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES C8402, M ALEXIS O WND PROT/RET 5/BX; KGW

Model Number	4
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
Investigation summary: the event unit was returned for evaluation.Upon visual inspection of the pouch, engineering discovered that the scratches went all the way through the tyvek layer at points and the sterile barrier was not maintained.The most likely root cause of the scratches is a cutter or a razor blade.It is possible that an operator accidentally scratched the tyvek with a cutter during manufacturing.The probability and criticality of harm resulting from this failure mode have been evaluated and were found to be at an acceptable level.Applied medical continuously seeks to improve the form, function, and ease of use of its products.As part of this continuous process, applied medical is currently researching possible process enhancements intended to further minimize the potential for this type of incident to occur.Applied medical will continue to monitor its vigilance system for trends and take appropriate actions, as necessary, to ensure the performance and safety of its products.
Event or Problem Description
No procedure performed/ inspection at distribution center - "the product did not pass the incoming inspection.Details are shown on the attached file." type of intervention - na.Patient status - na.

• Brand Name: C8402, M ALEXIS O WND PROT/RET 5/BX
• Common Device Name: KGW
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 6619156
• Report Number: 2027111-2017-01835
• Device Sequence Number: 495099
• Product Code: KGW
• UDI-Device Identifier: 00607915132958
• UDI-Public: (01)00607915132958(17)191219(30)01(10)1285499
• Combination Product (Y/N): N
• PMA/510(K) Number: 4
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/07/2017

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: 12/19/2019
• Device Model Number: 4
• Device Catalogue Number: 4
• Device Lot Number: 1285499
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2017
• Initial Report FDA Received Date: 06/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1