MAUDE Adverse Event Report: CAREFUSION, INC IP PREP SKIN TRAY 20/CS; SKIN PREP TRAY

Model Number	4437
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pr (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 customer found a bug on the packaging.
Additional Manufacturer Narrative
One photo was received by our quality team for evaluation.Upon visual inspection of the photo, something can be seen on the paper but due to the quality of the photo it is unclear what it is.A review of the internal manufacturing device records and raw material history files for the reported lot numbers was performed and no recorded quality problems or rejections to this incident were found.Storage and packaging areas were reviewed and no issues were found.All areas are frequently fumigated according to procedure and there also is an air curtains system to avoid insects from entering the facilities.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
It was reported that customer found a bug on the packaging.
Additional Manufacturer Narrative
One photo was received by our quality team for evaluation.Upon visual inspection of the photo, a meal worm can be seen.A review of the internal manufacturing device records and raw material history files for the reported lot numbers was performed and no recorded quality problems or rejections to this incident were found.Storage, assembly areas and packaging areas were reviewed and no issues were found.All areas are frequently fumigated according to procedure.The supplier also has very strong pest controls in the production line, in the principal aisle to the facility, internal perimeter and fences showed no signs of such insect.There are twice a month inspections and once a month fumigations.Each batch at the production line goes through a daily clearance for all work surfaces with isopropyl alcohol.Only certified (treated wood) pallet is used for palletizing and shipping.Also there is an air curtains system to avoid insects from entering the facilities.The records of reports on insects in the supplier medical plant were reviewed and there were no reports of insects on the dates related to the manufacture of the reported batch, the fumigation records were reviewed and the fumigations were performed on time.In addition, our suppliers of towels, gauze and sponge were asked to carry out an investigation in their facilities, however they did not find problems that could be related to this problem.We need the physical sample to be able to carry out a better investigation based on the kind of insect found.Therefore, the root cause cannot be determined.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.H3 other text: see narrative below.
Event or Problem Description
It was reported that customer found a bug on the packaging.

• Brand Name: IP PREP SKIN TRAY 20/CS
• Common Device Name: SKIN PREP TRAY
• Manufacturer (Section D): CAREFUSION, INC; 75 n. fairview drive; vernon hills IL 60061
• MDR Report Key: 11278801
• Report Number: 1423507-2021-00003
• Device Sequence Number: 11690167
• Product Code: OJU
• UDI-Device Identifier: 10885403175213
• UDI-Public: (01)10885403175213
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/17/2021

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: 4437
• Device Catalogue Number: 4437
• Device Lot Number: 0004119899
• Initial Date Received by Manufacturer: 01/08/2021
• Supplement Date Received by Manufacturer: 04/05/2021; 05/17/2021
• Initial Report FDA Received Date: 02/04/2021
• Supplement Report FDA Received Date: 04/08/2021; 05/20/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other