MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-09-16 for FRAZIER SUCTION TUBE 8FR 19-573 manufactured by Integra York, Pa Inc..
[26246254]
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
[26246255]
Customer reports (medwatch #(b)(4)) that a frazier 8 fr with control vent broke into 3 pieces while in the field. Surgeon was notified and through homeostasis, irrigation and suction the surgeon was satisfied no pieces remained in the patient.
Patient Sequence No: 1, Text Type: D, B5
[34091237]
On 10/16/2015 integra investigation completed. Method: failure analysis, device history evaluation. Results: failure analysis: failure analysis cannot be completed due to the lack of information received to perform a complete investigation. Product has not been returned for evaluation. Device history evaluation: dhr review. Nonconforming product report / nonconforming material report history: none. 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: root cause cannot be determined due to the lack of information received to perform a complete investigation. Product has not been returned for evaluation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2523190-2015-00095 |
| MDR Report Key | 5082494 |
| Date Received | 2015-09-16 |
| Date of Report | 2015-08-31 |
| Date of Event | 2015-06-11 |
| Date Mfgr Received | 2015-10-16 |
| Device Manufacturer Date | 2014-07-01 |
| Date Added to Maude | 2015-09-16 |
| 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 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 | FRAZIER SUCTION TUBE 8FR |
| Generic Name | M5 - GENERAL SURGERY |
| Product Code | EQH |
| Date Received | 2015-09-16 |
| Catalog Number | 19-573 |
| Lot Number | 072014AZC01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2015-09-16 |