MAUDE Adverse Event Report: CAREFUSION, INC ARTHROGRAM TRAY

Model Number	4325
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).
Event or Problem Description
It was reported that arthrogram tray had foreign matter in the tray.This was discovered before use.The following information was provided by the initial reporter: material no: 4325 batch no: 0001331662.It was reported that: debris found in sterile arthrogram trays on two different incident dates (6/1 and 6/4).I have received two reports of sterile arthrogram trays not being sterile upon opening.
Event or Problem Description
It was reported that arthrogram tray had foreign matter in the tray.This was discovered before use.The following information was provided by the initial reporter: material no: 4325; batch no: 0001331662.It was reported that: debris found in sterile arthrogram trays on two different incident dates (b)(6) and (b)(6)).I have received two reports of sterile arthrogram trays not being sterile upon opening.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 2020-06-26.H6: investigation summary: sample evaluations and evaluation of the pictures provided confirmed the reported failure mode with foreign matter located in/on the trays.A dhr review of all applicable manufacturing records for the lot did not identify any issues that may have contributed to the reported failure mode.Associates are required to wear proper ppe to minimize any transfer of debris from the associate or work area to the product.A review of the manufacturing process noted this product code is manually assembled.Based on the reported failure mode, the most likely source for this complaint was identified as inadvertent transfer of hair into the tray during the assembly of the unit.The investigation did note this product code is assembled in a controlled manufacturing environment with specific controls and requirements to minimize debris transfer into a finished good assembly.

• Brand Name: ARTHROGRAM TRAY
• Common Device Name: ARTHROGRAM TRAY
• Manufacturer (Section D): CAREFUSION, INC; 400 east foster rd; mannford OK 74044
• MDR Report Key: 10236902
• Report Number: 1625685-2020-00059
• Device Sequence Number: 2697577
• Product Code: OII
• UDI-Device Identifier: 10885403057137
• UDI-Public: 10885403057137
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2020

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: 09/30/2021
• Device Model Number: 4325
• Device Catalogue Number: 4325
• Device Lot Number: 0001331662
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2020
• Initial Date Received by Manufacturer: 06/12/2020
• Supplement Date Received by Manufacturer: 11/19/2020
• Initial Report FDA Received Date: 07/06/2020
• Supplement Report FDA Received Date: 11/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other