MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,08 report with the FDA on 2012-12-06 for SOPIRA CITOJECT BARREL ANG. 1.8ML 65429051 manufactured by .
[16058347]
Dealer notified heraeus of a citojet that the dentist alleges, "plunger breaks the anesthetic cartridges. "
Patient Sequence No: 1, Text Type: D, B5
[16425682]
As allowed by exemption# (b)(4), (the importer) is submitting the report on behalf of heraeus kulzer (b)(4) (the mfr). Although we have not established that the device caused or contributed to the event, we're reporting it out of caution to be complaint with 21 cfr part 803. This product is sold in the us under the catalog model # 66002394. It is only different in that the us distributed citojet has a standard thread. The unit in this has metric threading. The us distributed citojet has been on the market without incident since 1985. Conclusions: the device has a one year guarantee against defects. The unit in this report is well outside this guarantee period. Long term usage and handling could have contributed to the malfunction. The directions for use state, "please follow these instructions to maintain your sopira citojet syringe always in perfect working condition" and "please use needles with plastic hub only. A metal hub can damage threaded nozzle of the barrel in the long term. " the device has not been returned to the mfr therefore, there is no way to determine the cause of the malfunction.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9681707-2012-00012 |
| MDR Report Key | 2897627 |
| Report Source | 01,08 |
| Date Received | 2012-12-06 |
| Date of Report | 2012-11-06 |
| Date of Event | 2012-10-10 |
| Date Facility Aware | 2012-12-03 |
| Report Date | 2012-11-06 |
| Date Mfgr Received | 2012-11-06 |
| Device Manufacturer Date | 2007-07-01 |
| Date Added to Maude | 2013-01-17 |
| 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 | 3 |
| Manufacturer Contact | AUDI BOGUCKI, RDH |
| Manufacturer Street | 300 HERAEUS WAY |
| Manufacturer City | SOUTH BEND IN 46614 |
| Manufacturer Country | US |
| Manufacturer Postal | 46614 |
| Manufacturer Phone | 5742995409 |
| Manufacturer G1 | HERAEUS KULZER GMBH |
| Manufacturer Street | ALTE HEERSTRASSE/B 802 |
| Manufacturer City | DORMAGEN 41538 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 41538 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SOPIRA CITOJECT |
| Generic Name | EJI SYRINGE, CARTRIDGE |
| Product Code | EJI |
| Date Received | 2012-12-06 |
| Model Number | BARREL ANG. 1.8ML |
| Catalog Number | 65429051 |
| Lot Number | 07/07 |
| Operator | OTHER |
| Device Availability | N |
| Device Age | 5 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-12-06 |