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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. Lot number was provided. Will obtain expiration date and manufacture date and provide under a follow-up report to this initial report. 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 attached through the set's iv spikes to intravenous bags for fluid delivery during a trauma situation. At least one of the bags contained blood. The intravenous bags were placed in a 3m pressure infusor. No other pumps or pressure devices were being used. During blood delivery the tubing allegedly separated from the iv spike in the ranger tubing. Blood leaked, exposing a health care provider to blood. No injury was alleged to the health care provider or the patient although there was a delay in patient care while the issue was resolved.
 
Manufacturer Narrative
This follow-up report is providing the expiration date and manufacturing date applicable to the lot number provided under the initial report.
 
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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 Key6571117
MDR Text Key75310849
Report Number2110898-2017-00079
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 company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/17/2017
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 Expiration Date08/28/2019
Device Model NumberN/A
Device Catalogue Number24355
Device Lot NumberHX7803
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/17/2017
Was Device Evaluated by Manufacturer? No
Date Device Manufactured08/25/2016
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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