MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-12-18 for PREMIUM * ZCB manufactured by Crosstex International, Inc..
[5290097]
During an esophagogastroduodenoscopy (egd) the clinician was suctioning the patient's mouth and discovered the tip of the oral suction catheter had come off into the mouth of the patient. The physician was able to retrieve the plastic tip without incident or harm to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 4371917 |
| MDR Report Key | 4371917 |
| Date Received | 2014-12-18 |
| Date of Report | 2014-11-14 |
| Date of Event | 2014-10-20 |
| Report Date | 2014-11-14 |
| Date Reported to FDA | 2014-12-18 |
| Date Reported to Mfgr | 2014-12-30 |
| Date Added to Maude | 2014-12-30 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PREMIUM |
| Generic Name | SALIVA EJECTOR SUCTION CATHETER |
| Product Code | DYN |
| Date Received | 2014-12-18 |
| Model Number | * |
| Catalog Number | ZCB |
| Lot Number | 07/08/14 3 |
| ID Number | * |
| Device Availability | Y |
| Device Age | 5 MO |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CROSSTEX INTERNATIONAL, INC. |
| Manufacturer Address | 10 RANICK RD HAUPPAUGE NY 11788 US 11788 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-12-18 |