FDA Adverse Event
Malfunction
Summary report: N
JELCO HYPODERMIC NEEDLE-PRO DEVICE SYRINGE
MDR report key: 2851395
·
Received October 30, 2012
Report
- Report Number
- 2183502-2012-00511
- Event Type
- Malfunction
- Date Received
- October 30, 2012
- Date of Event
- September 26, 2012
- Report Date
- October 26, 2012
- Manufacturer
- SMITHS MEDICAL ASD, INC.
- Product Code
- FMJ
- PMA / PMN Number
- K923127
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
CUSTOMER HAS NOT YET RETURNED THE DEVICE TO THE MANUFACTURER FOR DEVICE EVALUATION. WHEN AND IF THE DEVICE BECOMES AVAILABLE AND IS RETURNED AND EVALUATED, THE MANUFACTURER WILL FILE A FOLLOW-UP REPORT DETAILING THE RESULTS OF THE EVALUATION.
Description of Event or Problem · 1
REPORT WAS RECEIVED THAT STATED DURING AN INJECTION VIA THE DEVICE, THE NEEDLE BECAME DETACHED FROM THE SYRINGE. THE NURSE REMOVED THE DETACHED NEEDLE. NO NEEDLESTICK TOOK PLACE. THERE WAS NO PATIENT OR CLINICIAN INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | JELCO HYPODERMIC NEEDLE-PRO DEVICE SYRINGE | NEEDLE, HYPODERMIC | FMJ | SMITHS MEDICAL ASD, INC. | NA | 1644897 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |