MAUDE Adverse Event Report: CAREFUSION, INC IP PREP SKIN TRAY; SKIN SCRUB TRAY

Model Number	4468
Medical Device Problem Code	Incomplete or Missing Packaging (2312)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Initial mdr.A follow up will be submitted if additional information becomes available.(b)(4).
Event or Problem Description
It was reported that the product were received in totes with no liners causing debris to get inside the product.
Event or Problem Description
It was reported that the product were received in totes with no liners causing debris to get inside the product.
Additional Manufacturer Narrative
This complaint will be cancelled and is no longer reportable.The issue involved was due to a shipping issue with the third-party distributor medline and not an issue with the bd product or transportation.Both the customer and medline confirmed and medline will be handling the complaint on their side now.The manufacturer of the product also completed an investigation and could not find any issues furthering the confirmation that it isn't a product issue.

• Brand Name: IP PREP SKIN TRAY
• Common Device Name: SKIN SCRUB TRAY
• Manufacturer (Section D): CAREFUSION, INC; 75 north fairway drive; vernon hills IL 60061
• MDR Report Key: 11207301
• Report Number: 1423507-2020-00064
• Device Sequence Number: 11887878
• Product Code: OJU
• UDI-Device Identifier: 10885403184475
• UDI-Public: (01)10885403184475
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 02/19/2021

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 Model Number: 4468
• Device Catalogue Number: 4468
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 12/24/2020
• Supplement Date Received by Manufacturer: 12/24/2020
• Initial Report FDA Received Date: 01/21/2021
• Supplement Report FDA Received Date: 02/19/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other