MAUDE Adverse Event Report: MEX03 MEXICO-JUAREZ PRESOURCE CARDIAC CATH PACK (CCEDC)677; CARDIAC CATHETERIZATION KIT

Model Number	SAN46CCEDD
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the device history record for lot number 20200213-23-sh, revealed a manufactured date of january 07th 2020.No exception was recorded in the device history record that could lead to the reported incident.Based on supplier investigation, the average linting data is 0.162 g / 10 pieces.No sample returned for investigation, only photo of sample was provided.The investigation of the photo provided revealed no abnormal situation.According to supplier, or towel is made of cotton, so cotton fiber is born.Supplier 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.From the investigation results, 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 supplier will continue to monitor trends for this type of incident.
Event or Problem Description
The customer reported surgeon was doing a peripheral procedure and as they were running the catheter, they started to develop small embolized fluff balls that could possibly go into the patient and cause a serious issue.There was no injury or adverse event to the (b)(6) year-old male patient that required additional medical treatment.
Additional Manufacturer Narrative
A review of the device history record for lot number 20200213-23-sh, revealed a manufactured date of january 07th 2020.No exception was recorded in the device history record that could lead to the reported incident.Based on supplier investigation, the average linting data is 0.162 g / 10 pieces.No sample returned for investigation, only photo of sample was provided.A second batch of photos were provided.A review of the second batch of photos revealed fluff balls were found on the surface of the product.According to supplier, or towel is made of cotton, so cotton fiber is born.Supplier 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.From the investigation results, 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 supplier will continue to monitor trends for this type of incident.

• Brand Name: CARDIAC CATH PACK (CCEDC)677
• Common Device Name: CARDIAC CATHETERIZATION 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: 10518871
• Report Number: 1423537-2020-00511
• Device Sequence Number: 3168302
• Product Code: OES
• UDI-Device Identifier: 10888439629866
• UDI-Public: 10888439629866
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 11/16/2020

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: SAN46CCEDD
• Device Catalogue Number: SAN46CCEDD
• Device Lot Number: 404931
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/11/2020
• Supplement Date Received by Manufacturer: 08/11/2020
• Initial Report FDA Received Date: 09/10/2020
• Supplement Report FDA Received Date: 11/16/2020
• Patient Sequence Number: 1
• Patient Age: 88 YR
• Patient Weight: 76