MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-06-26 for SUREBLOCK SPROTTE SPINAL NEEDLE ASA-25090-SB manufactured by Arrow International, Inc. (subsidiary Of Teleflex, Inc.).
| Report Number | MW5087642 |
| MDR Report Key | 8739513 |
| Date Received | 2019-06-26 |
| Date of Report | 2019-06-24 |
| Date Added to Maude | 2019-06-27 |
| 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 | 3 |
| Reporter Occupation | RISK MANAGER |
| 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 | SUREBLOCK SPROTTE SPINAL NEEDLE |
| Generic Name | SPINAL ANESTHESIA KIT |
| Product Code | OFU |
| Date Received | 2019-06-26 |
| Model Number | ASA-25090-SB |
| Catalog Number | ASA-25090-SB |
| Lot Number | 23F18L0024 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARROW INTERNATIONAL, INC. (SUBSIDIARY OF TELEFLEX, INC.) |
| Manufacturer Address | US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-06-26 |