FDA Adverse Event
Injury
Summary report: N
PREVENT BLOOD COLLECTION SET W/ SAFETY SHIELD
MDR report key: 2120251
·
Received June 7, 2011
Report
- Report Number
- 1058382-2011-00002
- Event Type
- Injury
- Date Received
- June 7, 2011
- Date of Event
- January 1, 2011
- Report Date
- April 25, 2011
- Manufacturer
- HINDUSTAN SYRINGES AND MEDICAL DEVICES, LTC.
- Product Code
- JKA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
ACTUAL DEVICE WAS NOT MADE AVAILABLE TO THE MANUFACTURER, ALTHOUGH SAMPLES FROM SAME LOT NUMBER WERE SENT TO US TO FORWARD TO THE MANUFACTURER. SAMPLES ARE IN TRANSIT OF THIS REPORT AND WILL BE EVALUATED BY THE MANUFACTURER.
Description of Event or Problem · 1
AS REPORTED FROM CUSTOMER, "NURSE WAS USING BUTTERFLY AND WAS TRYING TO CLOSE IT AND THE NEEDLE SLIPPED TO THE SIDE AND STUCK HER. THE OFFICE MANAGER CHECKED AND SAID THAT NONE OF THIS LOT SEEM TO LOCK INTO THE HINGE. THE NURSE IS NOW ON MEDS FOR SIX MONTHS DUE TO (B)(6) POSSIBILITY."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PREVENT BLOOD COLLECTION SET W/ SAFETY SHIELD | SET, ADMINISTRATION, INTERVASCULAR | JKA | HINDUSTAN SYRINGES AND MEDICAL DEVICES, LTC. | PSS7001P2350 | 1143 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |