MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-31 for ARROW IPN045627 ASA-24090-SB manufactured by Teleflex Incorporated.
[177188817]
While doctor was attempting to give patient spinal anesthesia the 24 guage spinal needle was broken off beneath the skin surface. X-ray was called. Doctor was able to remove the broken needle. Image was read by radiology and it was determined there was nothing left in the wound.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9652594 |
| MDR Report Key | 9652594 |
| Date Received | 2020-01-31 |
| Date of Report | 2020-01-15 |
| Date of Event | 2020-01-09 |
| Report Date | 2020-01-15 |
| Date Reported to FDA | 2020-01-15 |
| Date Reported to Mfgr | 2020-01-31 |
| Date Added to Maude | 2020-01-31 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ARROW |
| Generic Name | NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER) |
| Product Code | BSP |
| Date Received | 2020-01-31 |
| Model Number | IPN045627 |
| Catalog Number | ASA-24090-SB |
| Lot Number | 23F19G0231 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX INCORPORATED |
| Manufacturer Address | PO BOX 12600 DURHAM NC 27709 US 27709 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-31 |