MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-11-09 for SUCTION TUBE MCEN79J30 DIA 3MM JANKOWSKI manufactured by Integra Microfrance S.a.s..
[59966680]
The device involved in the reported incident has been received for evaluation. An investigation has been initiated based on the reported information.
Patient Sequence No: 1, Text Type: N, H10
[59966681]
It was reported that the device broke during a nasal cavity procedure. No harm to the patient and the event did not lead to surgical delay.
Patient Sequence No: 1, Text Type: D, B5
[61564496]
Integra has completed their internal investigation on november 10, 2016. The investigation included: methods: evaluation of actual device, review of device history records, review of complaints history. Results: evaluation of returned device; product or objective evidence was returned and the evaluation verified the complaint as valid. The suction tube is broken on its proximal part. A thorough observation of the fracture area does no show visual evidence of a manufacturing or material defect. Dhr review; no anomalies that could be associated with the complaint were observed. Complaints history; first occurrence for this risk for this product family. No adverse trend. Conclusion: the cause of this breakage cannot be determined with absolute certainty. It may come from an undetected weakness of the tube at the welding level or an excessive constraint during suction tube insertion in the patient.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2523190-2016-00185 |
| MDR Report Key | 6090878 |
| Date Received | 2016-11-09 |
| Date of Report | 2016-10-13 |
| Date Mfgr Received | 2016-11-10 |
| Device Manufacturer Date | 2016-09-19 |
| Date Added to Maude | 2016-11-09 |
| 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 SONIA IRIZARRY |
| Manufacturer Street | 311 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362393 |
| Manufacturer G1 | INTEGRA MICROFRANCE S.A.S. |
| Manufacturer Street | LE PAVILLON |
| Manufacturer City | SAINT AUBIN LE MONIAL 03160 |
| Manufacturer Country | FR |
| Manufacturer Postal Code | 03160 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SUCTION TUBE MCEN79J30 DIA 3MM JANKOWSKI |
| Generic Name | PFM11 |
| Product Code | JZF |
| Date Received | 2016-11-09 |
| Returned To Mfg | 2016-10-18 |
| Catalog Number | MCEN79J30 |
| Lot Number | 1647850 |
| 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 MICROFRANCE S.A.S. |
| Manufacturer Address | LE PAVILLON LE PAVILLON SAINT AUBIN LE MONIAL 03160 FR 03160 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-11-09 |