MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES C8301, S ALEXIS WND PROT/RET 5/BX; KGW

Model Number	C8301
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 device is anticipated to return.A follow-up report will be provided upon completion of investigation.There is no report of serious injury or death associated with this event.
Event or Problem Description
Procedure performed na - "we have been informed that a nurse found a hole on the package of alexis (c8301).The hole was found on (b)(6) and it seemed to be made by a cutter-knife.In our inspection process, we never use a cutter-knife and keep it away during inspection." "so, just in case, i would like to make sure if you have any process where your workers use a cutter knife near the products or possibility that the products contact with a cutter knife.I'm looking forward to your prompt reply." applied medical received additional information from the sale distributor on march 20,2017: the product was being stored in the operation theater and the facility does not use a box cutters to open the outer box.There are not pictures of the white boxes, brown boxes, or the storage location.Type of intervention - na.Patient status - na.
Additional Manufacturer Narrative
The event product unit was returned to applied medical for evaluation.Upon evaluation, engineering confirmed the complainant's experience of a hole on the tyvek side of the package and determined that the sterile barrier of the pouch was compromised.The pouch damage was likely caused when handling the packaged product while a sharp object, for example, a razor blade, was present.It cannot be confirmed where or when the pouch damage occurred.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.

• Brand Name: C8301, S ALEXIS 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: 6457315
• Report Number: 2027111-2017-01674
• Device Sequence Number: 875321
• Product Code: KGW
• UDI-Device Identifier: 00607915117207
• UDI-Public: (01)00607915117207(17)170615(30)01(10)1224718
• Combination Product (Y/N): N
• PMA/510(K) Number: K041711
• 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,Followup
• Report Date (Section B): 05/02/2017

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: 06/15/2017
• Device Model Number: C8301
• Device Catalogue Number: 100726601
• Device Lot Number: 1224718
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/17/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/04/2017
• Supplement Report FDA Received Date: 05/02/2017
• Patient Sequence Number: 1