MAUDE Adverse Event Report: MEX03 MEXICO-JUAREZ PRESOURCE DESERT SPRING HEART 1 AND 2 PK(OHDSC)839; CARDIOVASCULAR PROCEDURE KIT

Model Number	SCV73OHDSC
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/27/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the supplier investigation, the device history record (dhr) could not be reviewed as lot number was not provided.There were 3 occurrences of linting reported in the past 12 months.No sample was returned for investigation.According to the supplier, the workers shall do the visual test for every piece of product before folding and remove any foreign matters.The foreign matters is always being controlled as a key defect factor.They do sampling inspection during the process and for the final products.The process sampling criteria is l-1, acceptable quality level (aql) : 1.0.And for the final product, it is l-1, aql:0.65.From the investigation, no abnormal situation was found in production and no sample was returned for investigation so the root cause could not be determined.The complaint information was informed to the relevant sectors for their awareness.There is no action taken at this time, but the supplier will continue to monitor the trend of this type of incident.
Event or Problem Description
Customer reported linting of the lap sponges ls1818psa from the heart pack scv73ohdsc.The surgeon stated that the linting was so bad that he is concerned that it should be documented as a retained foreign body and now they are removing from all kits prior to a procedure.No patient demographics or further clinical data was provided upon request.

• Brand Name: DESERT SPRING HEART 1 AND 2 PK(OHDSC)839
• 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: 10589970
• Report Number: 1423537-2020-00529
• Device Sequence Number: 2386033
• Product Code: OEZ
• UDI-Device Identifier: 00885425802176
• UDI-Public: 00885425802176
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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): 09/25/2020

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: SCV73OHDSC
• Device Catalogue Number: SCV73OHDSC
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/27/2020
• Initial Report FDA Received Date: 09/25/2020
• 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