MAUDE Adverse Event Report: MEX03 MEXICO-JUAREZ PRESOURCE CARDIAC CATH LAB PACK (CC37B)212; CARDIOVASCULAR PROCEDURE KIT

Model Number SAN58CC37C

Device Problem Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/22/2021

Event Type  malfunction  

Manufacturer Narrative

From the device history record, lot# 20200622-23-sh was finished on 09th jul 2020.No exception was recorded in the device history record (dhr) that could lead to the reported incident.The average linting data is 0.202g / 10 pieces.There are 155 occurrences reported in the past 12 months.No sample returned for investigation.According to our supplier, the 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 do it according to standard operation procedure requirement., linting test method and acceptable criteria was stipulated to see the suction results.(b)(4).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 happened in production or dhr.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.

Event Description

Customer reported that during a cardiac catheterization, excessive lint came off the blue cotton or towels pwtb04-stm from the cardiac cath lab pack san58cc37c and was found on instrument and sterile field.No injury was reported.

• Brand Name: CARDIAC CATH LAB PACK (CC37B)212
• Type of Device: CARDIOVASCULAR PROCEDURE KIT
• Manufacturer (Section D): MEX03 MEXICO-JUAREZ PRESOURCE; c. arcadia 1580 , col. terraza; cd.juarez , chihuahua CP 32 599; MX CP 32599
• Manufacturer (Section G): MEX03 MEXICO-JUAREZ PRESOURCE; c. arcadia 1580 , col. terraza; cd.juarez , chihuahua CP 32 599; MX CP 32599
• Manufacturer Contact: patricia tucker ; 3651 birchwood drive; waukegan, IL 60085 ; 8478874151
• MDR Report Key: 11531865
• MDR Text Key: 241384111
• Report Number: 1423537-2021-00614
• Device Sequence Number: 1
• Product Code: OEZ
• UDI-Device Identifier: 10888439447941
• UDI-Public: 10888439447941
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SAN58CC37C
• Device Catalogue Number: SAN58CC37C
• Device Lot Number: 538172
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/23/2021
• Date Device Manufactured: 11/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other