MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,other report with the FDA on 2020-01-29 for ARNDT ENDOBRONCHIAL BLOCKER SET C-AEBS-9.0-78-SPH-AS manufactured by Cook Inc.
[177370005]
Pma/510(k) #: k160542. This report includes information known at this time. A follow-up report will be submitted should additional relevant information become available.
Patient Sequence No: 1, Text Type: N, H10
[177370006]
It was reported that black spots were seen on an arndt endobronchial blocker set in two different places prior to opening the package. No patient contact was made. No adverse effects were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2020-00232 |
| MDR Report Key | 9643427 |
| Report Source | DISTRIBUTOR,FOREIGN,OTHER |
| Date Received | 2020-01-29 |
| Date of Report | 2020-01-29 |
| Date of Event | 2020-01-16 |
| Date Mfgr Received | 2020-01-17 |
| Device Manufacturer Date | 2019-10-15 |
| Date Added to Maude | 2020-01-29 |
| 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 | UNK JENNIFER CANADA |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal | 47404 |
| Manufacturer Phone | 8123392235 |
| Manufacturer G1 | COOK INC |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 47404 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ARNDT ENDOBRONCHIAL BLOCKER SET |
| Generic Name | CBI TUBE, TRACHEAL/BRONCHIAL |
| Product Code | CBI |
| Date Received | 2020-01-29 |
| Model Number | NA |
| Catalog Number | C-AEBS-9.0-78-SPH-AS |
| Lot Number | 10083573 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK INC |
| Manufacturer Address | 750 DANIELS WAY BLOOMINGTON IN 47404 US 47404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-29 |