MAUDE Adverse Event Report: MEDTRONIC EXTENDED; UNO EWIS BLUE 60/9 HCAP 10PK INT

Lot Number 5364660

Device Problem Loss of or Failure to Bond (1068)

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

Event Type  malfunction  

Event Description

Unomedical reference number: 1550057.Event occurred in france.On (b)(6) 2022, the patient's reported that the catheter detached from the plastic part.Further, the catheters lasted between 3 to 5 days instead of 7.Moreover, it was not the dressing that came off but the plastic part that came off the dressing and the cannula.No further information available.

• Brand Name: MEDTRONIC EXTENDED
• Type of Device: UNO EWIS BLUE 60/9 HCAP 10PK INT
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 14751113
• MDR Text Key: 302932674
• Report Number: 8021545-2022-00151
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05705244022805
• UDI-Public: 05705244022805
• Combination Product (y/n): Y
• PMA/PMN Number: K210544
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/21/2022

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
• Device Expiration Date: 08/01/2023
• Device Lot Number: 5364660
• Initial Date Manufacturer Received: 06/11/2022
• Initial Date FDA Received: 06/21/2022
• Patient Sequence Number: 1