MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,user facility report with the FDA on 2015-12-14 for ASPIRATING SYRINGE TYPE C 1009808 manufactured by Integra York, Pa Inc..
[33425328]
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
[33425329]
Customer initially reports the aspirating syringe cracked and broke. (b)(6) 2015 customer reports doctor was injecting medication when the thumb ring on the syringe broke off, no harm done.
Patient Sequence No: 1, Text Type: D, B5
[33975771]
On (b)(6) 2015 integra investigation completed. Failure analysis, device history evaluation. Aspirating syringe returned in used condition, not showing any unusual markings. There was an aspirating syringe returned with scratches. Evaluation of the syringe was completed by placing a carpule into the syringe and advancing the plunger. The syringe is functioning as designed. 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: there is no applicable variance authorization / deviation history. Engineering change order/manufacturing change order history: there is no applicable engineering change order/manufacturing change order history. Corrective action preventive action history: none. Health hazard evaluation history: none. The complaint has been unconfirmed; testing within specifications.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2523190-2015-00137 |
| MDR Report Key | 5294183 |
| Report Source | DISTRIBUTOR,USER FACILITY |
| Date Received | 2015-12-14 |
| Date of Report | 2015-11-30 |
| Date of Event | 2015-10-07 |
| Date Mfgr Received | 2015-12-15 |
| Date Added to Maude | 2015-12-14 |
| 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 | 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 | 2015-12-14 |
| Returned To Mfg | 2015-12-03 |
| Catalog Number | 1009808 |
| 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 | 2015-12-14 |