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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

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3M HEALTH CARE 3M RANGER(TM) HIGH FLOW BLOOD/FLUID DISPOSABLE SET HIGH FLOW DISPOSABLE TUBING Back to Search Results
Model Number N/A
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Not Applicable (3189)
Event Date 04/18/2017
Event Type  malfunction  
Manufacturer Narrative
No patient involved and no reported injury. No lot number was provided. Without the lot number it is not possible to determine the expiration date or manufacture date. Product used was not returned to determine cause of reported event.
 
Event Description
A nurse reported that a 3m ranger(tm) high flow blood/fluid disposable set was used in a demonstration. No patient was involved. The nurse allegedly applied a minimum amount of pressure to the tubing attached to the iv spikes in the set. The tubing detached from the spikes.
 
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Brand Name3M RANGER(TM) HIGH FLOW BLOOD/FLUID DISPOSABLE SET
Type of DeviceHIGH FLOW DISPOSABLE TUBING
Manufacturer (Section D)
3M HEALTH CARE
2510 conway ave
st. paul MN 55144
Manufacturer (Section G)
NYPRO PRECISION ASSEMBLIES
sor juana ines de la cruz
cd. industrial
tijuana, tijuana baja california 22444
MX 22444
Manufacturer Contact
linda johnsen
3m center, building 275-5w-06
2510 conway ave
st. paul, MN 55144
6517374376
MDR Report Key6571108
MDR Text Key75311905
Report Number2110898-2017-00078
Device Sequence Number1
Product Code DWJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K973741
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation
Type of Report Initial
Report Date 04/18/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/16/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number24355
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/18/2007
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 05/16/2017 Patient Sequence Number: 1
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