MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-12-22 for SPINAL EPIDURAL KIT manufactured by Arrow Intl.
[16453974]
During a combined spinal/epidural procedure, upon removal of the catheter, the catheter snapped and broke off. A portion of the catheter is imbedded in the patient. The anesthesiologist left a message with the manufacturer regarding this matter.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5039794 |
| MDR Report Key | 4364756 |
| Date Received | 2014-12-22 |
| Date of Report | 2014-12-22 |
| Date of Event | 2014-12-21 |
| Date Added to Maude | 2014-12-30 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | PHARMACIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SPINAL EPIDURAL KIT |
| Generic Name | SPINAL EPIDURAL KIT |
| Product Code | OFT |
| Date Received | 2014-12-22 |
| Lot Number | 23F14H0737 |
| ID Number | ASK05560JMHI |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARROW INTL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-12-22 |