D
Patient 1
CUSTOMER REPORTED A MINOR INJURY WHILE RUNNING A PT SAMPLE ON THE AFFIRM ASSAY. A TECH PUNCTURED HER FINGER ON A GLASS SHARD INSIDE THE SPECIMEN TUBE. THE WOUND REQUIRED BASIC FIRST AID AND THE TECH WILL RECEIVED BASELINE TESTING.
MAUDE MDR 3625097
- MDR report key
- 3625097
- Report number
- 1119779-2014-00008
- Event key
- 0
- Event type
- 3
- Date of event
- 2014-01-17
- Date received
- 2014-02-05
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 100
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 0
Manufacturer Contact#
- Contact
- CHARLOTTE DANNENFELSER
- Address
- 7 LOVETON CIR. SPARKS MD 21152 US
- Phone
- 410-410-4103
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | AFFIRM VPIII AMBIENT TEMPERATURE TRANSPORT | BECTON, DICKINSON | LIO | 446255 | 3038199 | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2014-02-05 | 0 | 1. R |
Event Narratives#
N
Patient 1
THE AFFIRM ATTS COLLECTION KIT IS USED TO STABILIZE THE NUCLEIC ACID OF CANDIDA SPECIES, GARDNERELLA VAGINALIS, AND TRICHOMONAS VAGINALIS DURING SPECIMEN TRANSPORT AT AMBIENT TEMPERATURE (15-30 DEGREES CELSIUS) OR (2-8 DEGREES CELSIUS) FOR UP TO 72H. BD DETERMINED THAT IN THIS SITUATION THAT THE CUSTOMER DID NOT FOLLOW THE TESTING PROCEDURE. PER TECHNICAL SVS, THE CUSTOMER OPENED THE TIP OF THE PLASTIC DROPPER WHEN DISPENSING THE ATTS SOLUTION INTO THE SAMPLE TUBE. THIS ALLOWED THE GLASS TO BE POURED INTO THE SAMPLE TUBE. (B)(4) NO CORRECTIVE ACTION WILL BE INITIATED AT THIS TIME. BD WILL CONTINUE TO MONITOR FOR TRENDS.