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	01/28/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pr 2509135 initial emdr submission.A follow up emdr will be submitted if additional information becomes available.Imdrf annex e code health effect ¿ clinical code: e2403.Imdrf annex a code medical device problem code: a041001.No samples or photos were available for evaluation.Unfortunately, as a result, bd was unable to verify the reported issue or define a root cause at this time.Previously investigated records from the sample facility/reporter were investigated and it was determined the supplier, baldur systems corp, of the gloves were informed and asked to start an investigation to reach a potential root cause.Production record review was unable to be completed as batch/lot information is unavailable.No further actions are required at this time.This failure will continue to be tracked and trended.
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: 11583386
• Report Number: 1423507-2021-00017
• Device Sequence Number: 4881883
• 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
• Report Date (Section B): 03/02/2021

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 Model Number: 4468
• Device Catalogue Number: 4468
• Device Lot Number: UNKNOWN
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/02/2021
• Initial Report FDA Received Date: 03/29/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other