MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-07-16 for J-TIP NEEDLE FREE INJECTOR manufactured by National Medical Products Inc..
[2816601]
There have been several events in which the j-tip applicators break at point of administration. This has resulted in several near miss events in which rn administrating the medication and the pt to which medication was being administered were at risk for injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5026203 |
| MDR Report Key | 2664360 |
| Date Received | 2012-07-16 |
| Date of Report | 2012-07-16 |
| Date of Event | 2012-07-09 |
| Date Added to Maude | 2012-07-24 |
| 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 | 0 |
| Reporter Occupation | PHARMACIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | J-TIP NEEDLE FREE INJECTOR |
| Generic Name | J-TIP NEEDLE FREE INJECTOR |
| Product Code | KZE |
| Date Received | 2012-07-16 |
| Lot Number | 1203001 |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NATIONAL MEDICAL PRODUCTS INC. |
| Manufacturer Address | 57 PARKER ST. IRVINE CA 92718 US 92718 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-07-16 |