FDA Adverse Event
Malfunction
Summary report: N
INSYTE AUTOGUARD
MDR report key: 134669
·
Received November 20, 1997
Report
- Report Number
- 1710034-1997-00038
- Event Type
- Malfunction
- Date Received
- November 20, 1997
- Date of Event
- October 1, 1997
- Manufacturer
- *
- Product Code
- FOZ
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
Narratives
Additional Manufacturer Narrative · 1
THE MEDWATCH REPORT WAS FILED BASED ON INFO REC'D INDICATING THAT A NEEDLE STICK INJURY HAD OCCURRED. THE MEDWATCH REPORT WAS BASED ON ERRONEOUS INFO REC'D AND HAS SINCE BEEN CLARIFIED. ADDITIONAL INFO REC'D FROM REPORTER INDICATED THAT A NEEDLE STICK INJURY DID NOT OCCUR WITH THIS UNIT. CLARIFICATION OF THE EVENT INDICATED THAT THE UNIT FAILED TO RETRACT BUT A NEEDLE STICK INJURY DID NOT OCCUR. SUBMITTED SUPPLEMENTAL 02/01/1999.
Description of Event or Problem · 1
NEEDLESTICK INJURY OCCURRED IN ER DEPT. THE RN REPORTED THE NEEDLE DID NOT RETRACT AFTER PUSHING THE BUTTON THREE OR FOUR TIMES. SHE TURNED TO PLACE THE UNIT IN A SHARPS CONTAINER WHEN SHE WAS BUMPED BY A CO-WORKER. THE EXPOSED NEEDLE WENT INTO HER FINGER. PROTOCOL TESTING COMPLETED AND RESULTS NEGATIVE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INSYTE AUTOGUARD | PERIPHERAL VENOUS ACCESS CATHETER | FOZ | * | NA | 708156 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |