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	01/11/2022
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 that customer received wet prep tray with foreign matter.Verbatim" ¿ i received a bd wet prep preoperative skin prep tray from same day surgery while getting ready to prep for a gyn case for dr.(b)(6) today, the nurse noticed a hair in the betadine prep tray, ref# (b)(4), lot# 004197449, exp.Date: 2023-05-31.
Additional Manufacturer Narrative
A sample was provided for evaluation.Visual inspection was performed and found a hair inside of the tray on the gloves (p/n 76-89).As a result, bd was able to verify the reported issue.P/n 76-89 is a component provided by an external supplier.A quality notification has been created and sent to the supplier.The device history record of the p/n 4468 with lot number 0004197449 was reviewed in order to detect any issue related with the defect reported by the customer during its manufacturing.The complete lot was manufactured on 25oct 2021 per our internal procedures and no issues were found.No further actions are required.This failure will continue to be tracked and trended.H3 other text : see narrative below.
Event or Problem Description
It was reported that customer received wet prep tray with foreign matter.Verbatim" ¿ i received a bd wet prep preoperative skin prep tray from same day surgery while getting ready to prep for a gyn case for dr.(b)(6) today, the nurse noticed a hair in the betadine prep tray, ref# 4468, lot# 004197449, exp.Date: 2023-05-31.

• 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: 13459048
• Report Number: 1423507-2022-00003
• Device Sequence Number: 6199719
• Product Code: OJU
• UDI-Device Identifier: 10885403184475
• UDI-Public: (01)10885403184475
• Combination Product (Y/N): Y
• Initial Reporter State: AL
• 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,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/18/2022

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: 05/31/2023
• Device Model Number: 4468
• Device Catalogue Number: 4468
• Device Lot Number: 0004197449
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/11/2022
• Supplement Date Received by Manufacturer: 02/18/2022
• Initial Report FDA Received Date: 02/04/2022
• Supplement Report FDA Received Date: 02/18/2022
• 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