MAUDE Adverse Event Report: MEX03 MEXICO-JUAREZ PRESOURCE KIT,ADULT OPEN HEART (H03A )122; CARDIOVASCULAR PROCEDURE KIT

Model Number	PC3BOH036
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/01/1980
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
At the time of this investigation, the device history record could not be verified as a lot number was not provided., a review of complaints for this catalog number over the last 12 months indicated that this was the 2nd incident reported for this issue.No sample was available at the time of the investigation.Without the lot number and sample, the root cause could not be determined.The complaint information was informed to the relevant sectors for their awareness.Awareness documented training was provided to the employees involved in the process of this product.There is no action taken at this time, but we will continue to monitor the trend of this type of incident.
Event or Problem Description
Customer reported the tiburon drape a47042tnsa from the adult open heart kit pc3boh036 fell apart during a procedure and a contamination to the patient occurred.Customer would not provide any other details, event date or patient demographics when asked.

• Brand Name: KIT,ADULT OPEN HEART (H03A )122
• Common Device Name: CARDIOVASCULAR PROCEDURE 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: 10612904
• Report Number: 1423537-2020-00533
• Device Sequence Number: 14260963
• Product Code: OEZ
• UDI-Device Identifier: 10888439821451
• UDI-Public: 10888439821451
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/01/2020

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: Health Professional
• Device Model Number: PC3BOH036
• Device Catalogue Number: PC3BOH036
• Device Lot Number: UNKNOWN
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/01/2020
• Initial Report FDA Received Date: 10/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other