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

Model Number	4461A
Medical Device Problem Codes	Contamination /Decontamination Problem (2895); Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).(b)(6) initial emdr submission.A follow up emdr will be submitted if additional information becomes available.
Event or Problem Description
Material no.: 4461a, batch no.: 0004173982.It was reported that a hair was found in the tray before use.Per email: can you forward this quality issue to the bd rep.Or found a hair in the dry preop skin prep tray.Ech # 007202, ref# 4461a, lot # 004173982.It was attached to one of the sponge sticks.
Additional Manufacturer Narrative
According to the supplier, lot number was reviewed and no issues were found.A sample was provided by the customer and it was observed that hair was on the component.The failure mode was confirmed with the sample received.The root cause is due to manufacturing personnel as dress code was not followed and caused the contamination.An employee awareness training was performed at the plant to ensure this is an isolated incident.H3 other text : see narrative below.
Event or Problem Description
Material no.: 4461a, batch no.: 0004173982.It was reported that a hair was found in the tray before use.Per email: can you forward this quality issue to the bd rep.Or found a hair in the dry preop skin prep tray.Ech # 007202, ref# 4461a, lot # 004173982.It was attached to one of the sponge sticks.See below.

• 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: 11696909
• Report Number: 3004932373-2021-00203
• Device Sequence Number: 3436616
• Product Code: OJU
• UDI-Device Identifier: 10885403142192
• UDI-Public: (01)10885403142192
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/13/2021

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: Health Professional
• Device Model Number: 4461A
• Device Catalogue Number: 4461A
• Device Lot Number: 0004173982
• Initial Date Received by Manufacturer: 03/24/2021
• Supplement Date Received by Manufacturer: 10/13/2021
• Initial Report FDA Received Date: 04/20/2021
• Supplement Report FDA Received Date: 10/13/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other