MAUDE Adverse Event Report: CAREFUSION, INC DRY SKIN PREP TRAY

Model Number	4461A
Medical Device Problem Codes	Contamination /Decontamination Problem (2895); Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/25/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4) initial emdr submission.A follow up emdr will be submitted if additional information becomes available.(b)(4).
Event or Problem Description
It was reported by the distributor that debris found on outside of sterile wrapper.Debris on outside sterile wrap.
Additional Manufacturer Narrative
A sample was received for evaluation.A visual inspection was performed and found a foreign material in the towel.Therefore, reported defect was verified.The probable root cause was a personnel/training - operator error - assembly issue.The personnel do the assembling of the towel in the tray and they must ensure the components are free of contamination or damage.An external supplier is used for material for the end product and could not be eliminated as a potential source of the issue.A device history record review was completed for batch/lot 0004175206 was reviewed in order to detect any issue related with the defect reported by the customer during its manufacturing.Personnel involved were trained on 26jul2021 and the external supplier was notified.Sample will be discarded.No further actions were required at this time.H3 other text : see narrative below.
Event or Problem Description
It was reported by the distributor that debris found on outside of sterile wrapper.Debris on outside sterile wrap.

• Brand Name: DRY SKIN PREP TRAY
• Common Device Name: DRY SKIN PREP TRAY
• Manufacturer (Section D): CAREFUSION, INC; 75 n. fairview drive; vernon hills IL 60061
• MDR Report Key: 12099650
• Report Number: 1423507-2021-00037
• Device Sequence Number: 11804532
• Product Code: OJU
• UDI-Device Identifier: 10885403142192
• UDI-Public: (01)10885403142192
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/11/2021

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: 09/09/2021
• Device Model Number: 4461A
• Device Catalogue Number: 4461A
• Device Lot Number: 0004175206
• Initial Date Received by Manufacturer: 06/04/2021
• Supplement Date Received by Manufacturer: 08/11/2021
• Initial Report FDA Received Date: 07/01/2021
• Supplement Report FDA Received Date: 08/11/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other