FDA Adverse Event
Other
Summary report: N
3M
MDR report key: 1492450
·
Received October 2, 2009
Report
- Report Number
- 2110898-2009-00025
- Event Type
- Other
- Date Received
- October 2, 2009
- Date of Event
- April 1, 2009
- Report Date
- October 1, 2009
- Product Code
- KGX
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DATE ERROR IN REPORTING WAS DISCOVERED. ONE MDR IS BEING BROKEN OUT INTO 6 MDRS. SEE MFR REPORT 2110898-2009-000009 FOR HISTORY.
Description of Event or Problem · 1
BREAKOUT OF MFR REPORT #2110898-2009-00009 - FROM 1 MDR TO 6 MDRS. WHEN MICROPORE TAPE WAS BEING USED TO SECURE TUBING FOR HEMODIALYSIS, THE VENOUS NEEDLE DISLODGED AND PATIENT LOST 100 ML OF BLOOD. NO FURTHER MEDICAL CARE REQUIRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 3M | MICROPORE SURGICAL TAPE | KGX | 1530-1 | 2014-01-AW |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |