MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2015-04-27 for HYPODEMIC NEEDLE-PRO DEVICE 4237 manufactured by Smiths Medical Inc..
[15232421]
The user facility reported that while trying to engage it safety, the needle punctured through the safety mechanism. This resulted in the needle being exposed. No adverse effects to the pt or clinician were reported.
Patient Sequence No: 1, Text Type: D, B5
[15371029]
Customer has not yet returned the device to the mfr for device eval. When and if the device becomes available and is returned and evaluated the mfr will file a f/u report detailing the results of the eval.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2183502-2015-00275 |
| MDR Report Key | 4740601 |
| Report Source | 06 |
| Date Received | 2015-04-27 |
| Date of Report | 2015-04-24 |
| Date of Event | 2015-04-13 |
| Report Date | 2015-04-24 |
| Date Reported to FDA | 2015-04-24 |
| Date Mfgr Received | 2015-04-16 |
| Device Manufacturer Date | 2014-11-21 |
| Date Added to Maude | 2015-06-09 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MICHELE SELIGA |
| Manufacturer Street | 1265 GREY FOX RD |
| Manufacturer City | ST. PAUL MN 55112 |
| Manufacturer Country | US |
| Manufacturer Postal | 55112 |
| Manufacturer Phone | 6516287604 |
| Manufacturer G1 | SMITHS MEDICAL ASD, INC. |
| Manufacturer Street | 10 BOWMAN DR. |
| Manufacturer City | KEENE NH 03431 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 03431 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HYPODEMIC NEEDLE-PRO DEVICE |
| Generic Name | MANOMETER, SPINAL-FLUID |
| Product Code | FMJ |
| Date Received | 2015-04-27 |
| Model Number | NA |
| Catalog Number | 4237 |
| Lot Number | 2863433 |
| ID Number | NA |
| Device Expiration Date | 2019-11-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 4 MO |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITHS MEDICAL INC. |
| Manufacturer Address | KEENE NH US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-04-27 |