D
Patient 1
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.
MAUDE MDR 3426889
- MDR report key
- 3426889
- Report number
- 3426889
- Event key
- 0
- Event type
- 3
- Date of event
- 2013-05-21
- Date received
- 2013-06-07
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 2
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Report source
- U
- Manufacturer link flag
- N
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | J-TIP | INJECTOR, FLUID | NATIONAL MEDICAL PRODUCTS, INC. | KZE | 0.25 ML | 8164-2001-25 | 130516-23831 | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2013-06-07 | 0 |