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

Model Number	4468
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/13/2021
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 per clinical department, there is a hair inside the tray.Verbatim: by way of this email, we would like to file the following product complaint: item: tray prep skin wet scrub care, manufacturer catalog #: 4468, lot #: 0004184317, quantity of defective product: 1 each.Issues: per clinical department, there is a hair inside the tray.Please kindly forward this product complaint to your company qa department appropriately.In addition, please provide us with investigation result report (once it¿s available).
Additional Manufacturer Narrative
No samples or photos are available for evaluation.As a result, bd was unable to verify the reported issue or determine a definitive root cause at this time.The device history record for the part number 4468 with lot number 0004184317 and udi code (b)(4) was reviewed in order to detect any issue related with the reported defect during its manufacturing.The complete lot was manufactured inspected and released on 11may2021 per our internal procedures and no issues were found.Personnel, process, material, equipment, environment and design did not contribute with the defect reported by the customer.No corrective or preventive actions were taken.Manufacturing personnel were notified about the complaint.H3 other text : see narrative below.
Event or Problem Description
It was reported per clinical department, there is a hair inside the tray.Verbatim: by way of this email, we would like to file the following product complaint: item: tray prep skin wet scrub care.Manufacturer catalog #: 4468.Lot #: 0004184317.Quantity of defective product: 1 each.Issues: per clinical department, there is a hair inside the tray.Please kindly forward this product complaint to your company qa department appropriately.In addition, please provide us with investigation result report (once it¿s available).

• Brand Name: IP SKIN SCRUB TRAY
• Common Device Name: SKIN SCRUB 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: 12778862
• Report Number: 1423507-2021-00050
• Device Sequence Number: 3485669
• Product Code: OJU
• UDI-Device Identifier: 10885403184475
• UDI-Public: (01)10885403184475
• Combination Product (Y/N): N
• Initial Reporter State: HI
• 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,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/09/2021

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 Expiration Date: 12/31/2022
• Device Model Number: 4468
• Device Catalogue Number: 4468
• Device Lot Number: 0004184317
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/09/2021
• Supplement Date Received by Manufacturer: 11/09/2021
• Initial Report FDA Received Date: 11/09/2021
• Supplement Report FDA Received Date: 11/09/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown