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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There are two manufacturers of the or cotton towels.Manufacturer aijing: based on supplier investigation, device history record (dhr) could not able to be reviewed as lot number was not provided.However, they reviewed the dhr for recent 12 months and found no discrepancy.There is 1 occurrence reported in the past 12 months.According to the supplier, the suction process was performed before the products' final folding.They reviewed 12 batches produced this year and all linting test data are within the acceptable range (=0.38 g/10 pieces).As there is no sample returned and lot number information not provided, the root cause could not be determined.There is no action taken at this time, but the supplier will continue to monitor the trend of this type of incident.Manufacturer jianerkang: based on supplier investigation, device history record could not able to be reviewed as lot number was not provided.Supplier reviewed the records in the last 2 years and no abnormal situation was found.There are 166 occurrences reported in the past 12 months.No sample was returned at the time of the investigation.According to supplier, or towel is made of cotton, so cotton fiber is born.Supplier is continuously working with cardinal health to better control the linting and have implemented several measures to improve it: suctions machines have been installed in grey cloth rolling process, dyeing process and cutting process the suction process was added before product's final folding and workers perform it according to standard operation procedure requirement.Linting test method and acceptable criteria was stipulated to see the suction results.(=0.38 g/10 pieces).In the folding process, supplier used one cloth pad under 100 pieces semi-finished products to avoid linting stuck onto the products during product's transfer.From the investigation, there is no abnormal situation happened in production.Therefore, 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 or cotton towels pwtb04-stm 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 any 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: 10590308
• Report Number: 1423537-2020-00531
• Device Sequence Number: 19429601
• 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: 09/01/2020
• 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