MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-11-07 for PORTEX? SPINAL NEEDLE SETS 100/496/127 manufactured by Smiths Medical Asd, Inc..
[92199349]
(b)(6). This device is same and/or similar to a device approved for distribution in the us.
Patient Sequence No: 1, Text Type: N, H10
[92199350]
It was reported that a grey, square, plastic part disconnected from the stylet of a spinal needle. This issue occurred during stylet withdrawal. No patient injury was reported and no medical intervention was required.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012307300-2017-02353 |
| MDR Report Key | 7007692 |
| Date Received | 2017-11-07 |
| Date of Report | 2018-01-08 |
| Date of Event | 2017-10-16 |
| Date Mfgr Received | 2018-01-03 |
| Device Manufacturer Date | 2017-04-13 |
| Date Added to Maude | 2017-11-07 |
| 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 | 0 |
| Brand Name | PORTEX? SPINAL NEEDLE SETS |
| Generic Name | SPINAL ANESTHESIA KIT |
| Product Code | OFU |
| Date Received | 2017-11-07 |
| Returned To Mfg | 2017-11-13 |
| Catalog Number | 100/496/127 |
| Lot Number | 3388088 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2017-11-07 |