MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2017-12-05 for PORTEX? SPINAL NEEDLE SETS 100/496/122 manufactured by Smiths Medical, Asd, Inc..
[93764464]
It was reported that during a lumbar puncture the hub of a portex? Spinal needle detached from the needle itself, leaving the latter in the patient's back. Following needle removal, a second lumbar puncture was required. The needle was removed with forceps. There was no other associated injury.
Patient Sequence No: 1, Text Type: D, B5
[108799899]
One used needle was received for investigation. Through visual inspection it was confirmed that the needle had become detached from the needle hub. The supplier performed additional investigation on the device but could not identify a root cause for the needle detachment. The supplier did note the possibility of detaching the needle from the hub with use of excessive force.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3012307300-2017-02504 |
| MDR Report Key | 7084167 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-12-05 |
| Date of Report | 2018-05-21 |
| Date of Event | 2017-11-06 |
| Date Mfgr Received | 2018-04-23 |
| Device Manufacturer Date | 2017-07-06 |
| Date Added to Maude | 2017-12-05 |
| 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 SETS |
| Generic Name | NEEDLE, SPINAL, SHORT TERM |
| Product Code | MIA |
| Date Received | 2017-12-05 |
| Catalog Number | 100/496/122 |
| Lot Number | 3436028 |
| Operator | PHYSICIAN |
| Device Availability | * |
| 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 | 2017-12-05 |