| Brand Name | MCKESSON BRANDS |
|---|
| Common Device Name | CATH, IV SFTY STR PUSH BUTTON BC BLU 22GX1" |
|---|
| Manufacturer (Section D) |
| HARSORIA HEALTHCARE |
| 110-111 phase iv |
| udyog vihar sector 18 |
| gurugram, haryana 12201 5 |
| IN 122015 |
|
|---|
| MDR Report Key | 24331829 |
|---|
| Report Number | 1451040-2026-00011 |
|---|
| Device Sequence Number | 5018325 |
|---|
| Product Code |
QOI
|
| UDI-Device Identifier | 10612479268026 |
|---|
| UDI-Public | 10612479268026 |
|---|
| Combination Product (Y/N) | N |
|---|
| Initial Reporter State | NY |
|---|
| Initial Reporter Country | US |
|---|
| Number of Events Summarized | 1 |
|---|
| Summary Report (Y/N) | N |
|---|
| Serviced by Third Party (Y/N) | N |
|---|
| Reporter Type |
Importer
|
|---|
| Initial Reporter Occupation |
Other Health Care Professional
|
|---|
| Type of Report
| Initial |
|---|
| Report Date (Section B) |
02/13/2026 |
|---|
| Report Date (Section F) |
02/13/2026 |
|---|
| 1 Device was Involved in the Event |
|
| 1 Patient was Involved in the Event |
|
| Is this an Adverse Event Report? |
Yes
|
|---|
| Is this a Product Problem Report? |
Yes
|
|---|
| Operator of Device |
Health Professional
|
|---|
| Device Catalogue Number | 200-IVRB221 |
|---|
| Device Lot Number | 41196/0742 |
|---|
| Was Device Available for Evaluation? |
No
|
|---|
| Is the Reporter a Health Professional? |
Yes
|
|---|
| Was the Report Sent to FDA? |
Yes
|
|---|
| Distributor Facility Aware Date | 02/06/2026 |
|---|
| Device Age | 12 MO |
|---|
| Event Location |
Outpatient Diagnostic Facility
|
|---|
| Date Report to Manufacturer | 02/13/2026 |
|---|
| Initial Date Received by Manufacturer | Not provided |
|---|
| Initial Report FDA Received Date | 02/13/2026 |
|---|
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N) |
No
|
|---|
| Patient Sequence Number | 1 |
|---|
| Patient Sex | Unknown |
|---|
| Date Report Sent to FDA | 02/13/2026 |
|---|
|
|
