MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2000-02-02 for MONOJECT CURVED TIP SYRINGE * 8881412012 manufactured by The Kendall Company.
[177398]
Customer phoned in complaint to mfr on 01/04/2000, stating being stuck by a needle that was found in a box of curved tip dental syringes. The box of syringes pt was placing hand into had no attached needle, however, customer admits being stuck by a 5cc syringe with an attached needle. Customer reports that needle was a bd plastic pack, and the words discard it were written on the syringe barrel. Customer reports that needle penetrated the skin.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1915484-2000-00002 |
| MDR Report Key | 261445 |
| Report Source | 07 |
| Date Received | 2000-02-02 |
| Date of Report | 2000-02-01 |
| Date of Event | 2000-01-04 |
| Date Facility Aware | 2000-01-04 |
| Report Date | 2000-02-01 |
| Date Reported to Mfgr | 2000-01-04 |
| Date Mfgr Received | 2000-01-04 |
| Date Added to Maude | 2000-02-10 |
| 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 | 0 |
| Reporter Occupation | DENTAL HYGIENIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | WARREN NIGHAN, RN |
| Manufacturer Street | 15 HAMPSHIRE STREET |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5082618155 |
| Manufacturer G1 | THE KENDALL COMPANY |
| Manufacturer Street | 1222 SHERWOOD RD |
| Manufacturer City | NORFOLK NE 68701 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 68701 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MONOJECT CURVED TIP SYRINGE |
| Generic Name | DENTAL SYRINGE |
| Product Code | ECB |
| Date Received | 2000-02-02 |
| Model Number | * |
| Catalog Number | 8881412012 |
| Lot Number | NO1364 |
| ID Number | * |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 253204 |
| Manufacturer | THE KENDALL COMPANY |
| Manufacturer Address | 15 HAMPSHIRE ST. MANSFIELD MA 02048 US |
| Baseline Brand Name | MONOJECT CURVED TIP SYRINGE |
| Baseline Generic Name | DENTAL SYRINGE |
| Baseline Model No | * |
| Baseline Catalog No | 8881412012 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2000-02-02 |