MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2020-01-09 for DYND43506 manufactured by Medline Industries Inc..
[174294271]
It was reported that a piece of the ett stylet casing was found in a patient's left lung via a chest x-ray. Reportedly, the patient was transferred to another facility for further care. The manufacturer received this information through a medwatch (mw5091490) which contained no contact information for the reporter or for the reporting facility. Multiple product lot numbers (59217091512, 59218102251, 59219010204, 59219030450, 59219040715, 59219050916, 59219061337) were reported in the medwatch and it is unknown which product lot number was involved in the reported incident. No additional information has been received by the manufacturer. No sample has been returned to the manufacturer for evaluation. A root cause for the reported incident was unable to be determined. Due to the reported incident, and in an abundance of caution, this medwatch is being filed. If additional relevant information becomes available a supplemental medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10
[174294272]
It was reported that a piece of the endotracheal tube (ett) stylet casing was found in a patient's left lung.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1417592-2019-00231 |
| MDR Report Key | 9568697 |
| Report Source | OTHER |
| Date Received | 2020-01-09 |
| Date of Report | 2020-01-09 |
| Date of Event | 2019-11-13 |
| Date Mfgr Received | 2019-12-19 |
| Date Added to Maude | 2020-01-09 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | NIGEL VILCHES |
| Manufacturer Street | THREE LAKES DRIVE |
| Manufacturer City | NORTHFIELD IL 600932753 |
| Manufacturer Country | US |
| Manufacturer Postal | 600932753 |
| Manufacturer Phone | 2249311458 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | 6FR,STYLET,ET TUBE |
| Product Code | BSR |
| Date Received | 2020-01-09 |
| Catalog Number | DYND43506 |
| Lot Number | SEE H10 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES INC. |
| Manufacturer Address | THREE LAKES DRIVE NORTHFIELD IL 600932753 US 600932753 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-01-09 |