MAUDE Adverse Event Report: INTEGRA YORK, PA INC. ASPIRATING SYRINGE TYPE C; M51 - GENERAL DENTISTRY

Catalog Number 76-70

Device Problem Connection Problem (2900)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/14/2015

Event Type  malfunction  

Manufacturer Narrative

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.

Event Description

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.

Manufacturer Narrative

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.

• Brand Name: ASPIRATING SYRINGE TYPE C
• Type of Device: M51 - GENERAL DENTISTRY
• Manufacturer (Section D): INTEGRA YORK, PA INC.; 589 davies drive; 589 davies drive; york PA 17402
• Manufacturer (Section G): INTEGRA YORK, PA INC.; 589 davies drive; york PA 17402
• Manufacturer Contact: sandra lee ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 5320825
• MDR Text Key: 34182412
• Report Number: 2523190-2015-00146
• Device Sequence Number: 1
• Product Code: EJI
• Combination Product (y/n): N
• PMA/PMN Number: K083796
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 12/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 76-70
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/29/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/16/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 65 YR