MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2018-03-12 for PORTEX? SPINAL NEEDLE SET 100/496/126 manufactured by Smiths Medical, Asd, Inc..
[102160745]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[102160746]
It was reported that a spinal needle from a portex? Spinal needle set broke off in the subcutaneous tissue. Through an additional skin incision the broken needle fragment can be removed. The patient has not been seriously injured and suffered no permanent damge.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012307300-2018-00567 |
| MDR Report Key | 7332488 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-03-12 |
| Date of Report | 2019-01-28 |
| Date of Event | 2018-02-07 |
| Date Mfgr Received | 2018-12-29 |
| Device Manufacturer Date | 2017-10-13 |
| Date Added to Maude | 2018-03-12 |
| 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 | 2018-03-12 |
| Returned To Mfg | 2018-03-01 |
| Catalog Number | 100/496/126 |
| Lot Number | 3475301 |
| 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 | 1. Required No Informationntervention | 2018-03-12 |