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	03/26/2021
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.
Event or Problem Description
Material no: 4461a, batch no: 0004165631.It was reported that a bug was found inside of the kit.Event description per attached email states: i hope things are well.I received a product complaint a moment ago concerning a bug found in the customer below's prep kit.Lot number, prep tray number, etc is all included below.Lynn who is the customer at the account who let us know of the issues email is l[omitted] the product was not used an immediately discarded.Thanks for any assistance you can provide.Have a wonderful day.Yes, you read that right.Today we found a bug in our prep kit.It looks to have been sterilized along with the kit as it was found under the sponge sticks, however, we chose not to use it.Does this get forwarded to bd? how does something like this get handled?.
Event or Problem Description
Material no: 4461a batch no: 0004165631.It was reported that a bug was found inside of the kit.Event description per attached email states: i hope things are well.I received a product complaint a moment ago concerning a bug found in the customer belows prep kit.Lot number, prep tray number, etc is all included below.Lynn who is the customer at the account who let us know of the issues email is l[omitted] the product was not used an immediately discarded.Thanks for any assistance you can provide.Have a wonderful day.Yes, you read that right.Today we found a bug in our prep kit.It looks to have been sterilized along with the kit as it was found under the sponge sticks, however, we chose not to use it.I attached a picture of the package label insert and the sterilized creature.Does this get forwarded to bd? how does something like this get handled?.
Additional Manufacturer Narrative
A photo was provided for the investigation.With the photo provided, the failure mode was confirmed as an insect was observed on the tray.According to the manufacture, the environment was reviewed and no issues were found, in addition all areas are fumigated according to their procedure and has a strong pest control measures in place.Twice a month inspections are conduced as well.A batch review was conducted and this was the first complaint for the reported failure mode of insect.At this time, the manufacture of the product could not determine a root cause.H3 other text : see below narrative section.

• 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
• Manufacturer (Section G): CAREFUSION, INC; 75 n. fairview drive; vernon hills IL 60061
• Manufacturer Contact: anna wehrheim ; 75 n. fairview drive; vernon hills, IL 60061 ; 8015652341
• MDR Report Key: 11697091
• Report Number: 1423507-2021-00028
• Device Sequence Number: 17022067
• 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: Other,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2021

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: 0004165631
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/26/2021
• Supplement Date Received by Manufacturer: 11/12/2021
• Initial Report FDA Received Date: 04/20/2021
• Supplement Report FDA Received Date: 11/12/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown