UMBILICAL CATHETER SNGL LUMEN 3.5FR
Received Nov 4, 2022 · Event occurred Sep 25, 2022
Report 3009211636-2022-00801 · MDR key 15724209
Device
Generic name
Catheter, Umbilical Artery
Manufacturer
Cardinal HealthModel number
8888160333Catalog number
8888160333
Product problems
- Break
- Break
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE DEVICE HISTORY RECORD (DHR) REVIEW COULD NOT BE PERFORMED BECAUSE A LOT NUMBER WAS NOT AVAILABLE. HOWEVER, ALL DHRS ARE REVIEWED TO MEET REGULATORY REQUIREMENTS PRIOR TO PRODUCT RELEASE. ONE CATHETER WAS RECEIVED FOR ANALYSIS AND INVESTIGATION. THE CATHETER SHOWED SIGNS OF USE. IT WAS CONFIRMED THAT THE DEVICE SHOWED A RUPTURE NEAR THE 23CM MARK. THE REPORTED ISSUE WAS CONFIRMED. BASED ON THE INFORMATION AVAILABLE ITS DETERMINED THAT THE CATHETER WAS IN GOOD CONDITION PRIOR USE AND THE EXACT ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED. THIS COMPLAINT WILL BE USED FOR TRACKING AND TRENDING PURPOSES.
Additional Manufacturer Narrative
ADDITIONAL INFORMATION: B4: EVENT DESCRIPTION WAS ADDED TO DUE TO INFORMATION RECEIVED FROM THE CUSTOMER.
Description of Event or Problem
ADDITIONAL INFORMATION RECEIVED FEBRUARY 1, 2023: THE CUSTOMER CLARIFIED THAT THE CATHETER DID NOT BREAK WHEN BEING REMOVED, IT WAS REMOVED BECAUSE IT BROKE.
Additional Manufacturer Narrative
THE DEVICE HISTORY RECORD (DHR) REVIEW COULD NOT BE PERFORMED BECAUSE A LOT NUMBER WAS NOT AVAILABLE. HOWEVER, ALL DHRS ARE REVIEWED TO MEET REGULATORY REQUIREMENTS PRIOR TO PRODUCT RELEASE. ONE CATHETER WAS RECEIVED FOR ANALYSIS AND INVESTIGATION. THE CATHETER SHOWED SIGNS OF USE. IT WAS CONFIRMED THAT THE DEVICE SHOWED A RUPTURE NEAR THE 23CM MARK. THE REPORTED ISSUE WAS CONFIRMED. BASED ON THE INFORMATION RECEIVED THAT THE CATHETER SNAPPED DURING REMOVAL, IT WAS DETERMINED THAT THE CATHETER WAS IN WORKING CONDITION DURING USE AND WAS DAMAGED DURING REMOVAL. THERE ARE NO FURTHER ACTIONS REQUIRED FOR THIS COMPLAINT BECAUSE THE OCCURRENCE IS BELOW WHAT IS EXPECTED AND THE ISSUE WAS NOT CONFIRMED AS MANUFACTURING RELATED. THIS COMPLAINT WILL BE USED FOR TRACKING AND TRENDING PURPOSES.
Description of Event or Problem
THE CUSTOMER REPORTED THEY HAD AN ARGYLE UMBILICAL CATHETER SNAP. THE CATHETER SNAPPED NEAR THE 24CM MARKING DURING REMOVAL. THE CATHETER WAS INSERTED ON (B)(6) 2022 AND REMOVED ON (B)(6) 2022. IT WAS NOT REPLACED. THERE WAS NO HARM TO THE PATIENT.
Additional Manufacturer Narrative
AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.