Brand Name | TRANSPAC TRIFURCATED MONITORING KIT, 60" TUBING, 3 3 ML FLUSH DEVICE, MICRODRIP |
Type of Device | TRANSPAC III DISPOSABLE STRAIGHT PRESSURE TRANSDUCER AND KIT |
Manufacturer (Section D) |
ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. |
avenida cuarzo no. 250 |
ensenada, b.cfa. 22790 |
MX 22790 |
|
MDR Report Key | 10534623 |
MDR Text Key | 206967697 |
Report Number | 9617594-2020-00395 |
Device Sequence Number | 1 |
Product Code |
DRS
|
UDI-Device Identifier | 00840619030032 |
UDI-Public | (01)00840619030032(17)220101(10)3964739 |
Combination Product (y/n) | N |
PMA/PMN Number | K061573 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Type of Report
| Initial,Followup |
Report Date |
08/17/2020 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 09/15/2020 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 01/01/2022 |
Device Catalogue Number | 011-0J988-01 |
Device Lot Number | 3964739 |
Was Device Available for Evaluation? |
No
|
Date Manufacturer Received | 10/21/2020 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Treatment | IV FLUIDS, BAXTER; IV FLUIDS, BAXTER |
|
|