ASPIRATING SYRINGE TYPE C 76-70

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2015-12-22 for ASPIRATING SYRINGE TYPE C 76-70 manufactured by Integra York, Pa Inc..

Event Text Entries

[34182412] To date the device involved in the reported incident has not been received for evaluation. An investigation has been initiated based on the reported information.
Patient Sequence No: 1, Text Type: N, H10


[34182413] Dis-engaged carpial from syringe and carpial comes off but rubber stopper stays on spear. Doctor has gotten pricked trying to remove rubber from spear.
Patient Sequence No: 1, Text Type: D, B5


[42408735] On 3/16/16 integra investigation closed. Date of manufacture: 2ea. 08/2014 & 2ea: 12/2014. Method: failure analysis, device history evaluation. Results: failure analysis - four syringes returned in used condition, not showing any unusual markings. The returned syringes showing wear, staining within the harpoon. To test: the syringes were loaded with a new carpule and a new needle attached. During the analysis of the instruments, it was noticed that two out of four did not engage with the harpoon. The remaining two, the stopper got stuck not releasing as intended, causing the carpule to get stuck and when taken out spilled the lidocaine. What was noticed was that the spear was slightly damaged on one of the syringes. Without knowing the differences to the hardness of the rubber or the tolerances and how the spear was inserted the cause is undetermined. The complaint report is confirmed. Device history evaluation - dhr review was completed with all history available. Nonconforming product report / nonconforming material report history: there is no applicable nonconforming product report/nonconforming material report history. Variance authorization / deviation history: none. Engineering change order/manufacturing change order history: there is no applicable engineering change order/manufacturing change order history. Corrective action preventive action history: there is no applicable corrective action preventive action history. Health hazard evaluation history: none. Conclusion: the root cause has not been identified as a workmanship or material deficiency.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2523190-2015-00146
MDR Report Key5320825
Report SourceUSER FACILITY
Date Received2015-12-22
Date of Report2015-12-15
Date of Event2015-05-14
Date Mfgr Received2016-03-16
Date Added to Maude2015-12-22
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationDENTIST
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactUSER SANDRA LEE
Manufacturer Street311 ENTERPRISE DRIVE
Manufacturer CityPLAINSBORO NJ 08536
Manufacturer CountryUS
Manufacturer Postal08536
Manufacturer Phone6099362393
Manufacturer G1INTEGRA YORK, PA INC.
Manufacturer Street589 DAVIES DRIVE
Manufacturer CityYORK PA 17402
Manufacturer CountryUS
Manufacturer Postal Code17402
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameASPIRATING SYRINGE TYPE C
Generic NameM51 - GENERAL DENTISTRY
Product CodeEJI
Date Received2015-12-22
Returned To Mfg2015-12-29
Catalog Number76-70
Lot NumberUNKNOWN
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerINTEGRA YORK, PA INC.
Manufacturer Address589 DAVIES DRIVE 589 DAVIES DRIVE YORK PA 17402 US 17402


Patients

Patient NumberTreatmentOutcomeDate
10 2015-12-22

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