SOPIRA CITOJECT BARREL ANG. 1.8ML 65429051

MAUDE Adverse Event Report

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 .

Event Text Entries

[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


MAUDE Entry Details

Report Number9681707-2012-00012
MDR Report Key2897627
Report Source01,08
Date Received2012-12-06
Date of Report2012-11-06
Date of Event2012-10-10
Date Facility Aware2012-12-03
Report Date2012-11-06
Date Mfgr Received2012-11-06
Device Manufacturer Date2007-07-01
Date Added to Maude2013-01-17
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location3
Manufacturer ContactAUDI BOGUCKI, RDH
Manufacturer Street300 HERAEUS WAY
Manufacturer CitySOUTH BEND IN 46614
Manufacturer CountryUS
Manufacturer Postal46614
Manufacturer Phone5742995409
Manufacturer G1HERAEUS KULZER GMBH
Manufacturer StreetALTE HEERSTRASSE/B 802
Manufacturer CityDORMAGEN 41538
Manufacturer CountryGM
Manufacturer Postal Code41538
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSOPIRA CITOJECT
Generic NameEJI SYRINGE, CARTRIDGE
Product CodeEJI
Date Received2012-12-06
Model NumberBARREL ANG. 1.8ML
Catalog Number65429051
Lot Number07/07
OperatorOTHER
Device AvailabilityN
Device Age5 YR
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0


Patients

Patient NumberTreatmentOutcomeDate
10 2012-12-06

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