FDA Adverse Event
Malfunction
Summary report: N
HYPODERMIC NEEDLE-PRO SYRINGE AND NEEDLE WITH NEEDLE PROTECT
MDR report key: 740386
·
Received July 22, 2005
Report
- Report Number
- 1217052-2005-00063
- Event Type
- Malfunction
- Date Received
- July 22, 2005
- Date of Event
- June 27, 2005
- Report Date
- June 29, 2005
- Manufacturer
- SMITHS MEDICAL ASD, INC.
- Product Code
- FMI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
RESULTS EVAL: THIS NEEDLE IS SUPPLIED FROM TERUMO MEDICAL CORP AND THEY HAVE BEEN NOTIFIED OF THIS EVENT. WE ARE ANTICIPATING SAMPLES FOR THE SAME DEVICE LOT. UPON RECEIPT OF THE SUPPLIER EVAL A FOLLOW-UP REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
USER ALLEGES THEY HAD ONE EVENT OF THE HYPODERMIC NEEDLE ADHESIVE SEAL, BETWEEN THE METAL AND PLASTIC, NOT HOLDING THUS ALLOWING NEEDLE TO DISASSEMBLE. NO REPORTED INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HYPODERMIC NEEDLE-PRO SYRINGE AND NEEDLE WITH NEEDLE PROTECT | ACCESSORY TO HYPODERMIC NEEDLES | FMI | SMITHS MEDICAL ASD, INC. | NA | K631882 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |