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..
[5265976]
The patient was in the procedure room for percutaneous endoscopic gastrostomy (peg) placement. The clinician was suctioning the patient using a saliva ejector that was connected to suction tubing. The clinician reported that the blue tip from saliva ejector came off and was in the patient's mouth. The physician was able to keep the tip in view with the endoscope until anesthesia arrived to secure airway, and intubate if needed. Code was called. One of the code/anesthesia team clinicians was able to retrieve the tip from the patient. The patient remained stable throughout incident and was transferred to the intensive care unit (icu) after the peg procedure was completed. The saliva ejector used for the procedure was sequestered. The device was retained and similar lots were removed from the stock location.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 4371907 |
| MDR Report Key | 4371907 |
| Date Received | 2014-12-18 |
| Date of Report | 2014-11-11 |
| Date of Event | 2014-11-10 |
| Report Date | 2014-11-11 |
| 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 | 09/0/14 1 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 3 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 |