MAUDE Adverse Event Report: MEX03 MEXICO-JUAREZ PRESOURCE KIT OPEN HEART, BARNES JEWIS(T23A )898; CARDIOVASCULAR PROCEDURE KIT

Model Number	PVVMHT231
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/22/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the device history record for lot number 20191107-23-sh, revealed the manufactured date was november 14th, 2019.No exception was recorded in the device history record that could lead to the reported incident.Based on the supplier¿s investigation, the average linting data is 0.160 g / 10 pieces.No sample was returned at the time of the investigation.According to the supplier, or towel is made of cotton, so cotton fiber is born.The 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 do 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.The investigation revealed no abnormal situation that happened during production; therefore, the root cause could not be determined.The complaint information was shared with the relevant sectors for their awareness.There is no action taken at this time, but the supplier will continue to monitor trends for this type of incident.
Event or Problem Description
The customer reported linting during right thoracotomy mitral valve replacement procedure.There was no injury or adverse effect to the patient.
Additional Manufacturer Narrative
A review of the device history record for lot number 20191107-23-sh, revealed the manufactured date was november 14th, 2019.No exception was recorded in the device history record that could lead to the reported incident.Based on the supplier¿s investigation, the average linting data is 0.160 g / 10 pieces.No sample was returned for investigation, but photos were provided.A review of the photos provided revealed no obvious lint found on the surface of the product.According to the supplier, operation room towel is made of cotton, so cotton fiber is born.The supplier is continuously working with cardinal health to better control the linting and have implemented several measures to improve it: a.Suctions machines have been installed in grey cloth rolling process, dyeing process and cutting process.B.The suction process was added before product's final folding, and workers do it according to standard operation procedure requirement.C.Linting test method and acceptable criteria was stipulated to see the suction results.(=0.38 g/10 pieces).D.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.The investigation revealed no abnormal situation happened during production; therefore, the root cause could not be determined.The complaint information was shared with the relevant sectors for their awareness.There is no action taken at this time, but the supplier will continue to monitor trends for this type of incident.

• Brand Name: KIT OPEN HEART, BARNES JEWIS(T23A )898
• 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: 10286637
• Report Number: 1423537-2020-00484
• Device Sequence Number: 3293815
• Product Code: OEZ
• UDI-Device Identifier: 10888439831795
• UDI-Public: 10888439831795
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2020

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: PVVMHT231
• Device Catalogue Number: PVVMHT231
• Device Lot Number: 438623
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/22/2020
• Supplement Date Received by Manufacturer: 06/22/2020
• Initial Report FDA Received Date: 07/16/2020
• Supplement Report FDA Received Date: 08/27/2020
• Patient Sequence Number: 1