MAUDE Adverse Event Report: MEX03 MEXICO-JUAREZ PRESOURCE VASCULAR ACCESS PACK (VAPEB)226; CARDIOVASCULAR PROCEDURE KIT

Model Number	SAN45VAPEC
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on supplier investigation, device history record could not be reviewed as lot number was not provided.There was no sample available for 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 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 100pieces semi-finished products to avoid linting stuck onto the products during product's transfer.Based on the investigation, no abnormal situation happened in 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 the trend of this type of incident.
Event or Problem Description
Customer reported an abundance of lint of the blue cotton or towels, pwtb04-stm from the vascular access pack, san45vapec.The issue was found before the procedure.Towels were removed and no injury was reported to patient.No patient demographics were provided when requested.

• Brand Name: VASCULAR ACCESS PACK (VAPEB)226
• 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: 11406461
• Report Number: 1423537-2021-00606
• Device Sequence Number: 19676132
• Product Code: OEZ
• UDI-Device Identifier: 10888439908220
• UDI-Public: 10888439908220
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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
• Report Date (Section B): 03/03/2021

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: SAN45VAPEC
• Device Catalogue Number: SAN45VAPEC
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/04/2021
• Initial Report FDA Received Date: 03/03/2021
• Patient Sequence Number: 1