MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2011-11-09 for J-TIP SYRINGE J-TIP 0.25 ML 8164-2001-25 manufactured by National Medical Products, Inc..
[2357632]
Syringe broke apart during activation. Injury to personnel using device required stitches.
Patient Sequence No: 1, Text Type: D, B5
[9465225]
Product was filled with medication by third party source and shipped to hospital (user). Product was evaluated and mfr could only duplicate reported event following storage of product (filled with medication) outside labeled storage conditions. At this time mfr believes product was stored (frozen) after filling and prior to use, causing cracking and when device was activated product broke. Product labeling and instructions for use state range product must be stored and to inspect product for damage prior to use. It is the understanding of the mfr that the third party pharmacy ships product with cold packs (ice) and product may have been stored refrigerated at user.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2027063-2011-00001 |
| MDR Report Key | 2347605 |
| Report Source | 99 |
| Date Received | 2011-11-09 |
| Date of Report | 2011-10-08 |
| Date of Event | 2011-10-11 |
| Device Manufacturer Date | 2011-04-01 |
| Date Added to Maude | 2012-07-13 |
| 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 |
| 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, NEEDLES |
| Product Code | KZE |
| Date Received | 2011-11-09 |
| Returned To Mfg | 2011-10-19 |
| Model Number | J-TIP 0.25 ML |
| Catalog Number | 8164-2001-25 |
| Lot Number | 1104001 |
| Device Expiration Date | 2013-04-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | * |
| 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 | 2011-11-09 |