MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-01-11 for ON-Q NERVE BLOCK TRAY manufactured by Kimberly-clark/ Halyard.
[64929649]
The anesthesiologist place the stimulating needle in the pt. The anesthesiologist asked the tech to aspirate. While aspirating, air was drawn into the syringe. No air is to be aspirated into the syringe. Route: nerve block. Therapy start date: (b)(6) 2016. Therapy end date: (b)(6) 2017. Diagnosis or reason for use: continuous stimulating nerve block- pain relief.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5067189 |
| MDR Report Key | 6245321 |
| Date Received | 2017-01-11 |
| Date of Report | 2017-01-10 |
| Date of Event | 2017-01-10 |
| Date Added to Maude | 2017-01-12 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | 0 |
| Brand Name | ON-Q NERVE BLOCK TRAY |
| Generic Name | ON-Q NERVE BLOCK TRAY |
| Product Code | OGJ |
| Date Received | 2017-01-11 |
| Returned To Mfg | 2017-01-10 |
| Lot Number | 0202446910 |
| Device Expiration Date | 2017-11-30 |
| Device Availability | R |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KIMBERLY-CLARK/ HALYARD |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 18 | 2017-01-11 |