MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-10-11 for SUNMED 9-0212-70 manufactured by .
[174271340]
The returned device showed the tip was not present however it does not show a fracture, splintering, or stress which would be present if the tip broke off. The straight edge leads to the tip never being there and this is supported that the end user could not find the tip via a bronchoscopy. Sunmed does not have inventory of this lot but looked at a lot close to the suspect device and found all ends present. The investigation is inconclusive and there is no trending for ends of the bougie not being completely formed.
Patient Sequence No: 1, Text Type: N, H10
[174271341]
The customer alleges that "tip broke off bougie. " no other details were provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1314417-2019-00056 |
| MDR Report Key | 9180969 |
| Date Received | 2019-10-11 |
| Date of Report | 2019-10-11 |
| Date of Event | 2019-09-10 |
| Date Added to Maude | 2019-10-11 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| 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 | SUNMED |
| Generic Name | ET INTRODUCER |
| Product Code | BSR |
| Date Received | 2019-10-11 |
| Model Number | 9-0212-70 |
| Lot Number | MD163 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-10-11 |