MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2018-01-10 for PORTEX? SPINAL NEEDLE SET 100/496/122 manufactured by Smiths Medical, Asd, Inc..
[96906612]
(b)(6).
Patient Sequence No: 1, Text Type: N, H10
[96906613]
It was reported that a needle from a portex? Spinal needle set broke off remaining in the spinal canal during a lumbar puncture. The needle was surgically removed. No other adverse health outcomes were reported.
Patient Sequence No: 1, Text Type: D, B5
[117974590]
No sample was returned. A photo was received that confirmed a needle breakage occurred. Review of manufacturing records, relevant to the reported lot number, was conducted. During this review, no discrepancies or anomalies were observed. Based on the available information, the complaint was unable to be confirmed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3012307300-2018-00066 |
| MDR Report Key | 7180305 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2018-01-10 |
| Date of Report | 2018-08-01 |
| Date Mfgr Received | 2018-07-02 |
| Device Manufacturer Date | 2015-10-16 |
| Date Added to Maude | 2018-01-10 |
| 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 | 2018-01-10 |
| Catalog Number | 100/496/122 |
| Lot Number | 3044453 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | DA |
| 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. Required No Informationntervention | 2018-01-10 |