MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2012-09-19 for J-TIP SYRINGE J-TIP 0.25 ML 8164-2001-25 manufactured by National Medical Products, Inc..
[16049547]
User reported malfunction, breakage of device(s) at user one unit tip broke, one unit cracked, on unit where the filling unit attaches broke off. Not normal practice but cannot report that the devices were not stored outside labeling storage conditions. Syringe broke apart during activation.
Patient Sequence No: 1, Text Type: D, B5
[16325541]
One hundred percent inspection visual 100x magnification of filled devices returned from pharmacy; 76 units - nine units showed cracking - 152 units in original sterile packaging - opened 100% inspection visual 100x magnification - zero defects found - all units filled and inspected at zero time - zero defects found. Testing outside normal storage condition in process - will report following completion of testing. Previous lot testing could only replicate this type of cracking when units were filled and frozen.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2027063-2012-00001 |
| MDR Report Key | 2765308 |
| Report Source | 06 |
| Date Received | 2012-09-19 |
| Date of Report | 2012-08-19 |
| Date Mfgr Received | 2012-08-23 |
| Device Manufacturer Date | 2012-07-01 |
| Date Added to Maude | 2013-01-08 |
| 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 |
| 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 | 2012-09-19 |
| Returned To Mfg | 2012-08-23 |
| Model Number | J-TIP 0.25 ML |
| Catalog Number | 8164-2001-25 |
| Lot Number | 1205001 |
| Device Expiration Date | 2014-05-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2012-09-19 |