MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES A0G04, SZ 5 INSERT STEALTH FIBRA 10/BX; DXC

Model Number	7
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/15/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event product was returned to applied medical for evaluation.A follow-up report will be provided upon completion of investigation.The event is now reportable due to the sterile barrier being compromised by the two small holes.
Event or Problem Description
We finished our receiving inspection for invoice #(b)(4).Some of the products did not pass the receiving inspection because of particulate matter and so on.We would like applied medical to issue credit memo for the rejected items.
Additional Manufacturer Narrative
The event product unit was returned to applied medical for evaluation.Upon evaluation, engineering confirmed the complainant's experience of product pouch damage and determined that the sterile barrier of the pouch had been compromised.The pouch damage likely occurred during shipping and handling.The probability and criticality of harm resulting from this failure mode has been evaluated and was found to be at an acceptable level.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: A0G04, SZ 5 INSERT STEALTH FIBRA 10/BX
• Common Device Name: DXC
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 6474308
• Report Number: 2027111-2017-01680
• Device Sequence Number: 18952397
• Product Code: DXC
• UDI-Device Identifier: 00607915114756
• UDI-Public: (01)00607915114756(17)210731(30)01(10)1275992
• Combination Product (Y/N): N
• PMA/510(K) Number: 7
• 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): 05/26/2017

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: 07/31/2021
• Device Model Number: 7
• Device Catalogue Number: 7
• Device Lot Number: 1275992
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/02/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/07/2017
• Supplement Report FDA Received Date: 05/26/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1