FDA Adverse Event
Malfunction
Summary report: N
NEEDLE, RBN-84
MDR report key: 2917884
·
Received December 20, 2012
Report
- Report Number
- 1211566-2012-00004
- Event Type
- Malfunction
- Date Received
- December 20, 2012
- Date of Event
- March 9, 2012
- Report Date
- November 5, 2012
- Manufacturer
- RANFAC CORP.
- Product Code
- KNW
- PMA / PMN Number
- 983187
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
RANFAC CORPORATION WAS UNABLE TO REPLICATE THE INCIDENT IDENTIFIED BY THE END USER. UNABLE TO DETERMINE A PROPER ROOT CAUSE AND IDENTIFY AN EFFECTIVE PREVENTIVE ACTION.
Description of Event or Problem · 1
PHYSICIAN HAD DIFFICULTY RETRIEVING SAMPLE FROM MEDICINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NEEDLE, RBN-84 | RBN-84 | KNW | RANFAC CORP. | 74050-06M | 23668K16 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |