MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-03 for CARR-LOCKE INJECTION NEEDLE 00711811 manufactured by Us Endoscopy / Steris Corporation.
[144268563]
Us endoscopy, 25ga carr-locke injection needle would not flush. Nothing was able to pass through needle, including saline solution. No visible defects were noted. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5086388 |
| MDR Report Key | 8582572 |
| Date Received | 2019-05-03 |
| Date of Report | 2019-05-01 |
| Date of Event | 2019-05-01 |
| Date Added to Maude | 2019-05-06 |
| 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 |
| 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 | CARR-LOCKE INJECTION NEEDLE |
| Generic Name | ENDOSCOPIC INJECTION NEEDLE |
| Product Code | FBK |
| Date Received | 2019-05-03 |
| Model Number | 00711811 |
| Catalog Number | 00711811 |
| Lot Number | 1903736 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | US ENDOSCOPY / STERIS CORPORATION |
| Manufacturer Address | MENTOR OH 44060 US 44060 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-03 |