MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-01-05 for J-TIP SYRINGE * manufactured by National Medical Products, Inc..
[2450779]
The pressurized j-tip syringe broke into several pieces on activation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2401935 |
| MDR Report Key | 2401935 |
| Date Received | 2012-01-05 |
| Date of Report | 2011-10-28 |
| Date of Event | 2011-10-12 |
| Report Date | 2011-10-28 |
| Date Reported to FDA | 2012-01-05 |
| Date Added to Maude | 2012-01-06 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | J-TIP SYRINGE |
| Generic Name | J-TIP 0.25 SYRINGE |
| Product Code | KZE |
| Date Received | 2012-01-05 |
| Returned To Mfg | 2011-10-10 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | NMP LOT # 1104001 |
| ID Number | * |
| Operator | NURSE |
| Device Availability | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NATIONAL MEDICAL PRODUCTS, INC. |
| Manufacturer Address | 57 PARKER STREET IRVINE CA 92618160 US 92618 1605 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-01-05 |