MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-06-07 for J-TIP 0.25 ML 8164-2001-25 manufactured by National Medical Products, Inc..
[16015444]
J-tip "exploded" while being administered prior to peripheral iv placement. Part of the j-tip closest to end shattered into small pieces. Medication did not work as intended. Defective j-tip given to ed pharmacist.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3426889 |
| MDR Report Key | 3426889 |
| Date Received | 2013-06-07 |
| Date of Report | 2013-06-07 |
| Date of Event | 2013-05-21 |
| Report Date | 2013-06-07 |
| Date Reported to FDA | 2013-06-07 |
| Date Reported to Mfgr | 2013-10-24 |
| Date Added to Maude | 2013-10-24 |
| 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 |
| Generic Name | INJECTOR, FLUID |
| Product Code | KZE |
| Date Received | 2013-06-07 |
| Model Number | 0.25 ML |
| Catalog Number | 8164-2001-25 |
| Lot Number | 130516-23831 |
| ID Number | * |
| Operator | NURSE |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NATIONAL MEDICAL PRODUCTS, INC. |
| Manufacturer Address | 57 PARKER STREET IRVINE CA 92618114 US 92618 1147 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-06-07 |