Brand Name | 3M RANGER(TM) HIGH FLOW BLOOD/FLUID DISPOSABLE SET |
Type of Device | HIGH 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 Key | 6571117 |
MDR Text Key | 75310849 |
Report Number | 2110898-2017-00079 |
Device Sequence Number | 1 |
Product Code |
DWJ
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K973741 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,health |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
05/17/2017 |
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
|
Device Operator |
Nurse
|
Device Expiration Date | 08/28/2019 |
Device Model Number | N/A |
Device Catalogue Number | 24355 |
Device Lot Number | HX7803 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
04/18/2107 |
Initial Date FDA Received | 05/16/2017 |
Supplement Dates Manufacturer Received | Not provided
|
Supplement Dates FDA Received | 06/06/2017
|
Was Device Evaluated by Manufacturer? |
No
|
Date Device Manufactured | 08/25/2016 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|
|
|