MAUDE Adverse Event Report: MEX03 MEXICO-JUAREZ PRESOURCE KIT, OPEN HEART SET UP (HNOJ )744; CARDIOVASCULAR PROCEDURE KIT

Model Number PC24OHNOJ

Device Problem Material Separation (1562)

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

Event Date 04/08/2021

Event Type  malfunction  

Manufacturer Narrative

Based on supplier investigation, device history record (dhr) could not be reviewed as lot number was not provided.However, supplier reviewed the record in the last 2 years, no abnormal situation was found.No sample was available for investigation.According to the supplier, the operating 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: 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.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 excessive linting of the blue or towels pwtb04-stm from the open heart setup kit pc24ohnoj.The towels were immediately removed and replaced after the linting was noticed.No injury reported.No further information was provided when asked.Report being filed for potential risk.

• Brand Name: KIT, OPEN HEART SET UP (HNOJ )744
• 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: 11773250
• MDR Text Key: 249041277
• Report Number: 1423537-2021-00631
• Device Sequence Number: 1
• Product Code: OEZ
• UDI-Device Identifier: 10888439181975
• UDI-Public: 10888439181975
• 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,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PC24OHNOJ
• Device Catalogue Number: PC24OHNOJ
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other