MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2008-07-18 for THE WAND WA-2050-301 NA manufactured by Milestone Scientific.
[876224]
A wand handpiece with a bonded 30-gauge 1" needle was used to perform a dental injection. The user assembled the handpiece and attached it to the drive unit. The user acknowledged "bending" the needle prior to the placing the needle to performing the injection. The injection was successful. Upon removal of the handpiece from the patient's mouth, the needle separated at the needle/hub interface. User confirmed the location of the needle fragment within the soft tissue and removed it without injury to the patient.
Patient Sequence No: 1, Text Type: D, B5
[8023892]
In the operators manual under basic operation, it recommends that the operator bend the handpiece and not the needle. The operator failed to follow these instructions and bent the needle. The operator disposed of the handpiece in question and we were, therefore, unable to conduct analysis on that device. Similar handpieces from the same lot number were reviewed and the needles were intact and bonded properly to the hub. Tests showed that bending the handpieces could cause them to break. No action by the manufacturer is planned at this time.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004082685-2008-00002 |
| MDR Report Key | 1078558 |
| Report Source | 05,07 |
| Date Received | 2008-07-18 |
| Date of Report | 2008-07-18 |
| Date of Event | 2008-06-17 |
| Date Mfgr Received | 2008-06-26 |
| Device Manufacturer Date | 2006-08-01 |
| Date Added to Maude | 2008-07-24 |
| 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 | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | STEPHEN SOLOMON |
| Manufacturer Street | 220 S. ORANGE AVE. |
| Manufacturer City | LIVINGSTON NJ 07039 |
| Manufacturer Country | US |
| Manufacturer Postal | 07039 |
| Manufacturer Phone | 9735352717 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | THE WAND |
| Generic Name | HANDPIECE |
| Product Code | EJI |
| Date Received | 2008-07-18 |
| Model Number | WA-2050-301 |
| Catalog Number | NA |
| Lot Number | 061109 |
| ID Number | NA |
| Device Expiration Date | 2011-11-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1046521 |
| Manufacturer | MILESTONE SCIENTIFIC |
| Manufacturer Address | 220 SOUTH ORANGE AVE. LIVINGSTON NJ 07039 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2008-07-18 |