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..
[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
| Report Number | 2523190-2015-00146 |
| MDR Report Key | 5320825 |
| Report Source | USER FACILITY |
| Date Received | 2015-12-22 |
| Date of Report | 2015-12-15 |
| Date of Event | 2015-05-14 |
| Date Mfgr Received | 2016-03-16 |
| Date Added to Maude | 2015-12-22 |
| 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 |
| Reporter Occupation | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | USER SANDRA LEE |
| Manufacturer Street | 311 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362393 |
| Manufacturer G1 | INTEGRA YORK, PA INC. |
| Manufacturer Street | 589 DAVIES DRIVE |
| Manufacturer City | YORK PA 17402 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 17402 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ASPIRATING SYRINGE TYPE C |
| Generic Name | M51 - GENERAL DENTISTRY |
| Product Code | EJI |
| Date Received | 2015-12-22 |
| Returned To Mfg | 2015-12-29 |
| Catalog Number | 76-70 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA YORK, PA INC. |
| Manufacturer Address | 589 DAVIES DRIVE 589 DAVIES DRIVE YORK PA 17402 US 17402 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-12-22 |