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

Model Number	4468
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/22/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4) initial mdr.A follow up will be submitted if additional information becomes available.(b)(4).No device received for evaluation.
Event or Problem Description
It was reported that the glove has a hole.
Additional Manufacturer Narrative
No photo or sample was received by our quality team for evaluation; therefore, the incident could not be verified.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.Based on the investigation, the root cause could be the material of the gloves.The supplier of the gloves was made aware of the issue.
Event or Problem Description
It was reported that the glove has a hole.

• Brand Name: IP PREP SKIN TRAY
• Common Device Name: SKIN SCRUB TRAY
• Manufacturer (Section D): CAREFUSION, INC; 75 north fairway drive; vernon hills IL 60061
• MDR Report Key: 10851500
• Report Number: 3004932373-2020-00126
• Device Sequence Number: 3254445
• Product Code: OJU
• UDI-Device Identifier: 10885403184475
• UDI-Public: (01)10885403184475
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2020

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 Expiration Date: 01/30/2021
• Device Model Number: 4468
• Device Catalogue Number: 4468
• Device Lot Number: 0004123773
• Initial Date Received by Manufacturer: 10/22/2020
• Supplement Date Received by Manufacturer: 11/18/2020
• Initial Report FDA Received Date: 11/17/2020
• Supplement Report FDA Received Date: 11/19/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other