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

Model Number	4468
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pr 2578901 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 gloves have holes.Per attached complaint details: incident/non-conformance description (include photo of non-conformance if available): the customer reported the gloves inside has holes in them.
Additional Manufacturer Narrative
No samples or photos were not available for evaluation.As a result, bd was unable to verify the reported issue.The defective gloves are supplied outside of bd and this supplier was notified of the ongoing issues.According to the supplier, the root cause for this issue is 'poor rotation of the mold'.It is speculated that there may be a thin spot on the fingertips of the glove, and the end users have a hole after using the glove.The thin fingertips may be due to the poor rotation of the mold base during production resulting in uneven adhesion of the material and thin fingertips.The manufacturing will continue to check the rotation mechanism of the mold base every day, if any abnormality occurs, it will be immediately eliminated and replaced.The frequency of mold base lubrications has been adjusted from twice a week to three times a week since (b)(6) 2020 to ensure that the mold base rotates smoothly.
Event or Problem Description
It was reported that gloves have holes.Per attached complaint details: incident/non-conformance description (include photo of non-conformance if available): the customer reported the gloves inside has holes in them.

• 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: 11627193
• Report Number: 1423507-2021-00022
• Device Sequence Number: 19653161
• Product Code: OJU
• UDI-Device Identifier: 10885403184475
• UDI-Public: (01)10885403184475
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/13/2021

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: 09/30/2021
• Device Model Number: 4468
• Device Catalogue Number: 4468
• Device Lot Number: 0004139417
• Initial Date Received by Manufacturer: 03/12/2021
• Supplement Date Received by Manufacturer: 04/13/2021
• Initial Report FDA Received Date: 04/07/2021
• Supplement Report FDA Received Date: 04/13/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other