MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2018-11-12 for COOK DOUBLE LUMEN EXTRA FIRM SOFT TIPPED AIRWAY EXCHANGE CATHETER C-CAE-11.0-100-DLT-EF-ST manufactured by Cook Inc.
[128251665]
Pma/510(k) #: exempt. 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
[128251666]
It was reported foreign matter, hair-like fiber, was found inside the sterile packaging of a cook double lumen extra firm soft tipped airway exchange catheter. As reported, this device did not make patient contact.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2018-03259 |
| MDR Report Key | 8061639 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-11-12 |
| Date of Report | 2019-01-11 |
| Date of Event | 2018-10-17 |
| Date Mfgr Received | 2019-01-07 |
| Device Manufacturer Date | 2018-07-20 |
| Date Added to Maude | 2018-11-12 |
| 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 | MR. LARRY POOL |
| 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 | COOK DOUBLE LUMEN EXTRA FIRM SOFT TIPPED AIRWAY EXCHANGE CATHETER |
| Generic Name | LRC CHANGER, TUBE, ENDOTRACHEAL |
| Product Code | LRC |
| Date Received | 2018-11-12 |
| Returned To Mfg | 2018-11-19 |
| Model Number | NA |
| Catalog Number | C-CAE-11.0-100-DLT-EF-ST |
| Lot Number | 9034224 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2018-11-12 |