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

Model Number	4468
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); Not Applicable (3189)
Date of Event	12/15/2020
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 the gloves has holes.
Additional Manufacturer Narrative
A sample was available for evaluation.Visual examination was done according to our internal procedures and holes in the gloves were observed.As a result, bd was able to verify the reported issue.Material could be related to the failure as there is a small chance that an affected glove wallet was included in the involved batch.The supplier for this material was informed and asked to start an investigation to reach a root cause.The supplier of the gloves, baldur systems corp, was notified to trigger an investigation and reach a root cause.No further actions are required at this time.This failure will continue to be tracked and trended.H3 other text : see narrative below.
Event or Problem Description
It was reported that the gloves has holes.

• 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
• MDR Report Key: 11366652
• Report Number: 3004932373-2021-00070
• Device Sequence Number: 3335645
• Product Code: OJU
• UDI-Device Identifier: 10885403184475
• UDI-Public: (01)10885403184475
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 02/26/2021

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 Expiration Date: 08/31/2021
• Device Model Number: 4468
• Device Catalogue Number: 4468
• Device Lot Number: 0004126456
• Initial Date Received by Manufacturer: 01/28/2021
• Supplement Date Received by Manufacturer: 02/26/2021
• Initial Report FDA Received Date: 02/23/2021
• Supplement Report FDA Received Date: 02/26/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other