MAUDE Adverse Event Report: MEX03 MEXICO-JUAREZ PRESOURCE KIT,OPEN HEART CON (HCOA )933; CARDIOVASCULAR PROCEDURE KIT

Model Number	PVCGOHCOA
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/1980
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complaint was forwarded to the manufacturing facility where it is currently still under investigation.A follow-up report will be filed once the results have been completed.
Event or Problem Description
Customer reported that during a coronary artery bypass graft, the or towels pwtb04-stm from the open heart kit pvcgohcoa were fraying, causing fibers to be left on gloves and instruments.The fraying material was wiped off instruments and staff had to change gloves during procedure.No injury reported.No patient demographics or event date provided.Report being filed for potential risk.
Additional Manufacturer Narrative
Mdr supplemental report being filed as the results of the investigation are ready.From the device history record, lot#20191211-23-sh was manufactured on 12th dec 2019.No exception was recorded in the device history record that could lead to the reported incident.No sample was returned for investigation, only photos were provided.There was no fray visible, but there was lint on the surface of the product.Supplier checked on their retained sample and the sample is intact without any fray on it.There is 1 occurrence reported in the past 12 months.According to supplier, operation room 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: a.Suction 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.(=0.38g/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.From the investigation, no abnormal situation was found in retained sample, production process and device history record.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 supplier will continue to monitor the trend of this type of incident.

• Brand Name: KIT,OPEN HEART CON (HCOA )933
• 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: 10347529
• Report Number: 1423537-2020-00493
• Device Sequence Number: 19536464
• Product Code: OEZ
• UDI-Device Identifier: 10888439637335
• UDI-Public: 10888439637335
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/07/2020

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: PVCGOHCOA
• Device Catalogue Number: PVCGOHCOA
• Device Lot Number: 386435
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/01/2020
• Supplement Date Received by Manufacturer: 07/01/2020
• Initial Report FDA Received Date: 07/30/2020
• Supplement Report FDA Received Date: 08/07/2020
• 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