Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NULL; CONNECTOR, BLOOD TUBING, INFUSION T
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

NULL; CONNECTOR, BLOOD TUBING, INFUSION T Back to Search Results
Device Problem Fluid/Blood Leak (1250)
Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/25/2021
Event Type  malfunction  
Event Description
It was reported that the connecter was found leaking after one day of indwelling.There was no patient harm.
 
Manufacturer Narrative
Other, other text: h6: event problem and evaluation codes: updated after device evaluation.H10: device evaluation: the device was returned for investigation.A visual inspection and functional test were performed.One flat filter and epifuse connector and filter cover and the catheter were returned.Visual inspection results: as a result of checking the sample, there was a crack in the female connector of the flat filter, and whitening was seen at the base of the female connector.Conclusion: the reported event was confirmed.Root cause: it is probable that the cause of this event was that a physical load was applied to the female connector and a crack occurred.However, it was not possible to identify the time when the problem occurred, and it was not possible to identify the root cause of the problem.The cause of the reported problem could not be determined.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Type of Device
CONNECTOR, BLOOD TUBING, INFUSION T
Manufacturer (Section G)
NULL
MDR Report Key12290821
MDR Text Key267244987
Report Number3012307300-2021-08154
Device Sequence Number1
Product Code FKB
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 03/09/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/06/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/01/2021
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received07/11/2021
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-