MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-12 for PORTEX LUMBAR PUNCTURE TRAY manufactured by Smiths Medical Asd, Inc..
[127074899]
Information was received that a smiths medical portex lumbar puncture tray needle had been displaced from the packaging. It was reported the packaging "appeared to be completely intact, however the needle was freely rolling around, with no needle covering in place, within the plastic packaging. " due to the needle displacement, an employee sustained a clean needle stick to the palmar surface of her right hand. No additional adverse patient effects were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012307300-2018-08135 |
| MDR Report Key | 8061664 |
| Date Received | 2018-11-12 |
| Date of Report | 2018-11-12 |
| Date of Event | 2018-10-04 |
| Date Mfgr Received | 2018-10-15 |
| Date Added to Maude | 2018-11-12 |
| 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 G1 | SMITHS MEDICAL NORTH AMERICA |
| Manufacturer Street | 10 BOWMAN DRIVE |
| Manufacturer City | KEENE NH 034310724 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 034310724 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | PORTEX LUMBAR PUNCTURE TRAY |
| Generic Name | LUMBAR PUNCTURE TRAY (ADULT & PEDIATRIC) |
| Product Code | PWY |
| Date Received | 2018-11-12 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2018-11-12 |