MAUDE Adverse Event Report: MEX03 MEXICO-JUAREZ PRESOURCE HUMC LEFT HEART KIT (LHHMJ)115; GENERAL SURGERY TRAY (KIT)

Model Number	SAN11LHHMK
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/02/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
From the device history record, lot number 11td04sh was reviewed.There was no exception recorded in the device history record that could lead to the reported incident.No sample was available for the investigation.According to cardinal health¿s supplier, the linting content of the batch does not exceed the standard operation procedure (sop) which the linting content will not exceed (b)(4) of towels.From the investigation, the root cause could not be determined.No action will be taken, however, cardinal health will continue to monitor for trends.
Event or Problem Description
Based on information received from the customer they stated the pack allegedly contained very poor-quality towels that is reportedly creating a lot of excess lint on the field.There was no injury to patient.

• Brand Name: HUMC LEFT HEART KIT (LHHMJ)115
• Common Device Name: GENERAL SURGERY TRAY (KIT)
• Manufacturer (Section D): MEX03 MEXICO-JUAREZ PRESOURCE; c. arcadia 1580 , col. terraza; cd.juarez , chihuahua CP 32 599; MX CP 32599
• MDR Report Key: 10875254
• Report Number: 1423537-2020-00564
• Device Sequence Number: 2671391
• Product Code: LRO
• UDI-Device Identifier: 10888439612509
• UDI-Public: 10888439612509
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/20/2020

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: No Information
• Device Model Number: SAN11LHHMK
• Device Catalogue Number: SAN11LHHMK
• Device Lot Number: 458803
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/02/2020
• Initial Report FDA Received Date: 11/20/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other