FDA Adverse Event
Other
Summary report: N
3M
MDR report key: 1492442
·
Received October 2, 2009
Report
- Report Number
- 2110898-2009-00022
- 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 2110898-2009-00009 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 NEEDLE VENOUS DISLODGED AND PATIENT LOST 200 ML OF BLOOD. TIME LOST ON DIALYSIS TO BE MADE UP ON NEXT 2 TREATMENTS. HEMATOCRIT WAS DRAWN. NO BLOOD TRANSFUSION WAS REQUIRED. NO 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 |