MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2013-11-20 for J-TIP SYRINGE J-TIP 0.25 ML 8164-2001-25 manufactured by National Medical Products, Inc..
[4166098]
User reported malfunction, breakage or device (s) at use. (b)(4). "event desc: j-tip "exploded" while being administered prior to peripheral iv placement. Part of the j-tip closes to end shattered into mall pieces. Medication did not work as intended. Defective j-tip given to ed pharmacist. " not normal practice but cannot report that the devices were not stored outside labeling storage conditions. Syringe broke apart during activation. Pharmacy lot number.
Patient Sequence No: 1, Text Type: D, B5
[11489641]
Manufacturer has tested units and found extreme heat (+ 140 degrees c) and extreme cooling (dry ice or freezer storage) can cause device to crack. These extreme temperatures are the only way the manufacturer could find cracking damage. No actual "breakage" occurred during testing but cracking of the main body of the device was observed. Attempt has been made to obtain device. If device is returned a follow-up will be filed with fda.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2027063-2013-00001 |
| MDR Report Key | 3599280 |
| Report Source | 06 |
| Date Received | 2013-11-20 |
| Date of Report | 2013-11-21 |
| Date of Event | 2013-05-21 |
| Date Mfgr Received | 2013-10-28 |
| Date Added to Maude | 2014-03-12 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | 57 PARKER ST. |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal | 92618 |
| Manufacturer Phone | 9492853517 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | J-TIP SYRINGE |
| Generic Name | SYRINGE, NEEDLESS |
| Product Code | KZE |
| Date Received | 2013-11-20 |
| Model Number | J-TIP 0.25 ML |
| Catalog Number | 8164-2001-25 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NATIONAL MEDICAL PRODUCTS, INC. |
| Manufacturer Address | 57 PARKER ST. IRVINE CA 92618 US 92618 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-11-20 |