FDA Adverse Event
Injury
Summary report: N
NIPRO SAFETOUCH TULIP SAFETYAVF NEEDLE
MDR report key: 7289013
·
Received February 22, 2018
Report
- Report Number
- 8041145-2018-00009
- Event Type
- Injury
- Date Received
- February 22, 2018
- Report Date
- March 8, 2018
- Manufacturer
- NIPRO (THAILAND) CORP., LTD.
- Product Code
- MPB
- PMA / PMN Number
- K071145
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Description of Event or Problem · 0
THE FACILITY ADMINISTRATOR TOLD THEIR NIPRO CLINICAL SPECIALIST THAT THEY HAD 2 NEEDLESTICK INJURIES LAST YEAR (2017). ADDITIONAL INFORMATION WAS REQUESTED ON 1/26/2018, 2/1/2018, 2/15/2018 AND 2/20/2018 BY PHONE AND/OR EMAIL, HOWEVER NO INFORMATION WAS PROVIDED.
Description of Event or Problem · 1
THE FACILITY ADMINISTRATOR TOLD THEIR NIPRO CLINICAL SPECIALIST THAT THEY HAD 2 NEEDLESTICK INJURIES LAST YEAR (2017). ADDITIONAL INFORMATION WAS REQUESTED ON 1/26/2018, 2/1/2018, 2/15/2018 AND 2/20/2018 BY PHONE AND/OR EMAIL, HOWEVER NO INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 132135 | NIPRO SAFETOUCH TULIP SAFETYAVF NEEDLE | SAFETY AVF NEEDLE | MPB | NIPRO (THAILAND) CORP., LTD. | FT+152530TP | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |