MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2017-10-16 for PORTEX? SPINAL NEEDLE SET 100/496/125 manufactured by Smiths Medical, Asd, Inc..
[89453369]
Patient Sequence No: 1, Text Type: N, H10
[89453370]
It was reported while attempting a spinal with the use if a portex? Spinal needle, the device broke. The device was not removed, but was under consideration by a neurosurgeon. The complaint was reported as unresolved as the patient had persistent low back pain. No other adverse health outcomes were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012307300-2017-02185 |
| MDR Report Key | 6953000 |
| Report Source | DISTRIBUTOR |
| Date Received | 2017-10-16 |
| Date of Report | 2017-10-16 |
| Date Mfgr Received | 2017-09-26 |
| Device Manufacturer Date | 2017-05-19 |
| Date Added to Maude | 2017-10-16 |
| 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 | DAVE HALVERSON |
| Manufacturer Street | 6000 NATHAN LANE NORTH |
| Manufacturer City | MINNEAPOLIS MN 55442 |
| Manufacturer Country | US |
| Manufacturer Postal | 55442 |
| Manufacturer Phone | 7633833310 |
| Manufacturer G1 | SMITHS MEDICAL INTERNATIONAL LTD. |
| Manufacturer Street | 52 GRAYSHILL ROAD |
| Manufacturer City | CUMBERNAULD, GLASGOW G68 9HQ |
| Manufacturer Country | UK |
| Manufacturer Postal Code | G68 9HQ |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PORTEX? SPINAL NEEDLE SET |
| Generic Name | NEEDLE, SPINAL, SHORT TERM |
| Product Code | MIA |
| Date Received | 2017-10-16 |
| Catalog Number | 100/496/125 |
| Lot Number | 3405509 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITHS MEDICAL, ASD, INC. |
| Manufacturer Address | 6000 NATHAN LANE NORTH MINNEAPOLIS MN 55442 US 55442 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-10-16 |