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: 3M HEALTH CARE 3M RANGER(TM) HIGH FLOW BLOOD/FLUID DISPOSABLE SET; HIGH FLOW DISPOSABLE TUBING
  • 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
 

3M HEALTH CARE 3M RANGER(TM) HIGH FLOW BLOOD/FLUID DISPOSABLE SET; HIGH FLOW DISPOSABLE TUBING Back to Search Results
Model Number N/A
Medical Device Problem Code Fluid/Blood Leak (1250)
Health Effect - Clinical Code Not Applicable (3189)
Date of Event 11/20/2020
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Patient's information: not available.Product has not been returned to 3m for analysis.3m¿ is unable to verify the leak, identify exact location and root cause without the sample.3m¿ will continue to monitor.
 
Event or Problem Description
A hospital alleged a 3m¿ ranger¿ high flow disposable set (model 24365) leaked at the side of the cassette.No patient/staff injury was alleged.No additional information was provided.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
3M RANGER(TM) HIGH FLOW BLOOD/FLUID DISPOSABLE SET
Common Device Name
HIGH FLOW DISPOSABLE TUBING
Manufacturer (Section D)
3M HEALTH CARE
2510 conway ave
st. paul MN 55144
MDR Report Key11091443
Report Number2110898-2020-00068
Device Sequence Number2702660
Product Code BSB
UDI-Device Identifier00707387781460
UDI-Public00707387781460
Combination Product (Y/N)N
Initial Reporter CountryCA
PMA/510(K) Number
K973741
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Administrator/Supervisor
Type of Report Initial,Followup
Report Date (Section B) 01/04/2021
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
Operator of Device Health Professional
Device Expiration Date10/10/2022
Device Model NumberN/A
Device Catalogue Number24365
Device Lot NumberHM8551
Was Device Available for Evaluation? Yes
Initial Date Received by Manufacturer 11/30/2020
Supplement Date Received by Manufacturer11/24/2020
Initial Report FDA Received Date12/29/2020
Supplement Report FDA Received Date01/04/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
-
-