MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 1999-07-01 for SPROTTE PENCIL POINT SPINAL NEEDLE (WITHOUT INTRODUCER) 03115130A manufactured by Rusch, Inc..
[156918]
It was reported that the pt was undergoing an elective cesarean section under spinal block anesthesia. An introducer was placed, and then the sprotte needle was placed. Spinal fluid was not obtained; the introducer and needle were removed. Upon removal, it was noted that the distal portion of the needle was not removed. After the procedure, the pt underwent an add'l procedure to remove the tip. No further consequences were noted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2429473-1999-00058 |
| MDR Report Key | 230157 |
| Report Source | 06 |
| Date Received | 1999-07-01 |
| Date of Report | 1999-06-29 |
| Date of Event | 1999-06-09 |
| Date Mfgr Received | 1999-06-17 |
| Date Added to Maude | 1999-07-07 |
| 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 | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SPROTTE PENCIL POINT SPINAL NEEDLE (WITHOUT INTRODUCER) |
| Generic Name | SPINAL NEEDLE |
| Product Code | GDM |
| Date Received | 1999-07-01 |
| Model Number | NA |
| Catalog Number | 03115130A |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 223213 |
| Manufacturer | RUSCH, INC. |
| Manufacturer Address | 2450 MEADOWBROOK PKWY. DULUTH GA 30096 US |
| Baseline Brand Name | SPROTTE PENCIL POINT SPINAL NEEDLE |
| Baseline Generic Name | SPINAL NEEDLE |
| Baseline Model No | NA |
| Baseline Catalog No | 03115130A |
| Baseline ID | NA |
| Baseline Device Family | EPIDURAL NEEDLE |
| Baseline Shelf Life Contained | * |
| Baseline Shelf Life [Months] | * |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K911260 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1999-07-01 |