Brand Name | CBC II KIT WITH 3/16" ROUND PVC WOUND DRAIN |
Type of Device | APPARATUS, AUTOTRANSFUSION |
Manufacturer (Section D) |
STRYKER INSTRUMENTS-PUERTO RICO |
las palmas industrial park |
highway #3, km 130.2 |
arroyo 00615 |
|
Manufacturer (Section G) |
STRYKER INSTRUMENTS-PUERTO RICO |
las palmas industrial park |
highway #3, km 130.2 |
arroyo 00615 |
|
Manufacturer Contact |
zachary
baker
|
4100 east milham avenue |
kalamazoo, MI 49001
|
2693237700
|
|
MDR Report Key | 7240429 |
MDR Text Key | 99087409 |
Report Number | 0001811755-2018-00383 |
Device Sequence Number | 1 |
Product Code |
CAC
|
UDI-Device Identifier | 4546540867698 |
UDI-Public | (01)4546540867698 |
Combination Product (y/n) | N |
PMA/PMN Number | K970714 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
user facility |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
02/05/2018 |
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 |
Health Professional
|
Device Catalogue Number | 0225426000 |
Device Lot Number | 16065012 |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
01/30/2018 |
Initial Date FDA Received | 02/05/2018 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 03/05/2016 |
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 |