MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-10-04 for BARON SUCTION TUBE 3 ANGLED 5FR 60-1003J manufactured by Integra York, Pa Inc..
[57059211]
Device history file: we investigated the device history file. No rework or failure was documented during the production. We produced (b)(4) pieces with this lot. The final inspection was done 100%. The final inspection is documented dated from 14. April 2015. Failure analysis: the suction instrument has been so badly damaged that only an identification of the article on the supplier code (b)(4) is possible. This suction pipe there is a massive use of force which had the complete destruction of the intake manifold result. The instrument has been misused with security and used with absolutely great violence.
Patient Sequence No: 1, Text Type: N, H10
[57059212]
Customer initially reports the baron suction tube 4 angled 5fr broke at hub during use in surgery. On (b)(6) 2016 customer reports device broke when suctioning nasal cavity, no harm done, no further information available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611610-2016-00001 |
| MDR Report Key | 5996479 |
| Date Received | 2016-10-04 |
| Date of Report | 2016-09-15 |
| Date Added to Maude | 2016-10-04 |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | BARON SUCTION TUBE 3 ANGLED 5FR |
| Generic Name | SUCTION TUBE |
| Product Code | JZF |
| Date Received | 2016-10-04 |
| Returned To Mfg | 2016-09-15 |
| Model Number | 60-1003J |
| Catalog Number | 60-1003J |
| Lot Number | 00850896/100110-1504 |
| Device Availability | R |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA YORK, PA INC. |
| Manufacturer Address | YORK 17402 US 17402 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-10-04 |