• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CADD EXTENSION SET TUBING SET, ADMINISTRATION, INTRAVASCULAR

  • 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
 

CADD EXTENSION SET TUBING SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Lot Number 4091449
Device Problem Fluid Leak (1250)
Patient Problem Insufficient Information (4580)
Event Type  malfunction  
Event Description
Spontaneous. Pt reports 4 of her cadd extension sets leaked around the filter area; date not provided. Lot number 4091449, expiration date 01/04/2026. Did the reported product fault occur while in use with the pt? no; did the product issue cause or contribute to pt or clinical injury? no; is the actual device available for investigation? yes; did we replace [mfr] the device? yes; did the pt have a backup they were able to switch to? yes; was the pt able to successfully continue their infusion? yes; is the infusion life-sustaining? yes. Reported to (b)(6) by pt/caregiver.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameCADD EXTENSION SET TUBING
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
MDR Report Key12662636
MDR Text Key277680694
Report NumberMW5104754
Device Sequence Number1
Product Code FPA
Combination Product (y/n)Y
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Type of Report Initial
Report Date 05/07/2021
4 Devices were Involved in the Event: 1   2   3   4  
0 Patients were Involved in the Event:
Date FDA Received10/18/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Lot Number4091449
Was Device Available for Evaluation? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

-
-