MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2008-12-09 for PILLING /WECK/ TELEFLEX manufactured by Teleflex Medical.
[18223965]
This patient was brought to the or for rigid bronchoscopy and tracheal dilatation. During the procedure, the tip of the dilator (#22 pilling) and the body of the dilator became separated. The tip lodged in the right main stem bronchus. The patient's sao2 and heart rate immediately dropped; cpr was initiated, et tube was inserted. After the patient was successfully resuscitated, the et tube was removed and dilatation continued. After the procedure, the patient was returned to the icu where he remained unresponsive to oral or pain stimuli. Device evaluated by mfr: not returned to mfr. The set of dilators was immediately pulled from service.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1352681 |
| MDR Report Key | 1352681 |
| Report Source | 99 |
| Date Received | 2008-12-09 |
| Date of Report | 2008-12-09 |
| Date of Event | 2008-11-25 |
| Date Facility Aware | 2008-11-25 |
| Report Date | 2008-12-09 |
| Date Reported to Mfgr | 2008-11-26 |
| Date Added to Maude | 2009-04-03 |
| 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 | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PILLING /WECK/ TELEFLEX |
| Generic Name | BRONCHIAL DILATOR |
| Product Code | KCG |
| Date Received | 2008-12-09 |
| ID Number | SIZE #22 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | NA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL |
| Manufacturer Address | P.O. BOX 12600 RESEARCH TRIANGLE PARK NC 27709 US 27709 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2008-12-09 |