FDA Adverse Event
Malfunction
Summary report: N
HEMODIALYSIS KIT: 2-L 15 FR X 28 CM
MDR report key: 1873368
·
Received September 17, 2010
Report
- Report Number
- 1036844-2010-00293
- Event Type
- Malfunction
- Date Received
- September 17, 2010
- Date of Event
- September 2, 2010
- Report Date
- September 16, 2010
- Manufacturer
- ARROW INTL., INC.
- Product Code
- MSD
- PMA / PMN Number
- K040078
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). F/U REPORT WILL BE FILED IF ADDITIONAL INFO BECOMES AVAILABLE.
Description of Event or Problem · 1
IT WAS REPORTED THAT WHEN THE CARTON OF PRODUCT WAS RECEIVED, THEY DISCOVERED THE BOTTOM OF THE CARTON WAS SLICED. THE LAST TRAY THE CUSTOMER REMOVED FROM THE CARTON HAD A SLICE IN THE WHITE OUTER WRAP. AS A RESULT, IT WAS NOT USED. THERE WAS NO DELAY IN TREATMENT, NO PT DEATH AND NO COMPLICATIONS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HEMODIALYSIS KIT: 2-L 15 FR X 28 CM | CHRONIC HEMODIALYSIS CATHETER PRODUCTS | MSD | ARROW INTL., INC. | RF0087912 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |