MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-03-06 for AIRLIFE TRI-FLO * T260C manufactured by Medical Components, Inc..
[20359444]
This catheter was used after a procedure. Upon removal of the suction catheter, it was noted that there was a defect in the catheter about 4 cm long. Since it is not known if this catheter was defective before use, the physician performed a laryngoscopy. No foreign body was found.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3697209 |
| MDR Report Key | 3697209 |
| Date Received | 2014-03-06 |
| Date of Report | 2014-03-06 |
| Date of Event | 2014-03-03 |
| Report Date | 2014-03-06 |
| Date Reported to FDA | 2014-03-06 |
| Date Reported to Mfgr | 2014-03-25 |
| Date Added to Maude | 2014-03-25 |
| 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 | 0 |
| 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 | AIRLIFE TRI-FLO |
| Generic Name | CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 D |
| Product Code | OFO |
| Date Received | 2014-03-06 |
| Model Number | * |
| Catalog Number | T260C |
| Lot Number | 0000577766 |
| ID Number | * |
| Operator | UNKNOWN |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDICAL COMPONENTS, INC. |
| Manufacturer Address | 1499 DELP DRIVE HARLEYSVILLE PA 19438 US 19438 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-03-06 |