Brand Name | PINNACLE® |
Type of Device | PINNACLE® TPN MANAGEMENT SYSTEM, |
Manufacturer (Section D) |
B. BRAUN MEDICAL INC. |
1601 wallace drive |
suite 150 |
carollton TX 75006 6690 |
|
Manufacturer (Section G) |
B. BRAUN MEDICAL INC. |
1601 wallace drive |
suite 150 |
carollton TX 75006 6690 |
|
Manufacturer Contact |
jonathan
severino
|
861 marcon blvd. |
allentown, PA 18109
|
4847197287
|
|
MDR Report Key | 16931020 |
MDR Text Key | 315219391 |
Report Number | 2523676-2023-00171 |
Device Sequence Number | 1 |
Product Code |
NEP
|
UDI-Device Identifier | 04046964447198 |
UDI-Public | (01)04046964447198 |
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional,User Facility |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial,Followup |
Report Date |
08/04/2023 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 05/15/2023 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | PC1000 |
Device Catalogue Number | PC1000 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 04/20/2023 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 08/10/2021 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
Required Intervention;
|