MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07,08 report with the FDA on 2012-10-15 for SOPIRA CITOJECT 1.8ML POINT. LA 65429094 manufactured by Heraeus Kulzer Gmbh.
[3087424]
Dealer notified heraeus of a citojet that the dentist alleges, "device jerks and breaks ampules. "
Patient Sequence No: 1, Text Type: D, B5
[10430281]
As allowed by (b)(4), (b)(4) (the importer) is submitting the report on behalf of heraeus kulzer (b)(4) (the manufacturer). This product is sold in the u. S, under the catalog model #66002392. It is only different in that the u. S. Distributed citojet has a flat plunger. The unit in this report has a plunger with a point. The u. S. Distributed citojet has been on the market without incident since 1985. Although, we have not established that the device caused or contributed to the event, we're reporting it out of caution to be compliant with 21 cfr part 803. The device required cleaning prior to evaluation and is outside of the warranty period of one year. The device was cleaned and is functioning well now. The device will be returned to the customer. Due to the aforementioned fact that the unit is out of warranty and the customer's failure to maintain, no further action is deemed necessary at this time. The investigation is closed. Capa measures are not proposed or initiated.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9681707-2012-00009 |
| MDR Report Key | 2799064 |
| Report Source | 01,07,08 |
| Date Received | 2012-10-15 |
| Date of Report | 2012-09-18 |
| Date Facility Aware | 2012-09-19 |
| Report Date | 2012-09-18 |
| Date Mfgr Received | 2012-09-24 |
| Device Manufacturer Date | 2009-06-01 |
| Date Added to Maude | 2012-11-01 |
| 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 | AUGI 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 |
| Remedial Action | OT |
| 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 | 2012-10-15 |
| Returned To Mfg | 2012-09-24 |
| Model Number | 1.8ML POINT. LA |
| Catalog Number | 65429094 |
| Lot Number | 0609 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 40 MO |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HERAEUS KULZER GMBH |
| Manufacturer Address | DORMAGEN GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-10-15 |