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 |