MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2019-10-22 for HUDSON ET TUBE, SHER-I-BRONCH, LS, 35 FR 5-16039 manufactured by Teleflex Medical.
[169879727]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[169879728]
Customer reported the physician was called into the room because of a circuit leak. The trach connection was found "50% broken off". It was reported the physician tried to fix the connection with tegaderm and that is when it broke off. No patient harm reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003898360-2019-01239 |
| MDR Report Key | 9217913 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2019-10-22 |
| Date of Report | 2019-09-30 |
| Date of Event | 2019-09-27 |
| Date Mfgr Received | 2019-10-24 |
| Device Manufacturer Date | 2019-08-01 |
| Date Added to Maude | 2019-10-22 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | KATHARINE TARPLEY |
| Manufacturer Street | 3015 CARRINGTON MILL BLVD |
| Manufacturer City | MORRISVILLE NC 27560 |
| Manufacturer Country | US |
| Manufacturer Postal | 27560 |
| Manufacturer Phone | 9194334854 |
| Manufacturer G1 | TELEFLEX MEDICAL |
| Manufacturer Street | RANCHO EL DESCANSO |
| Manufacturer City | TECATE 21478 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 21478 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HUDSON ET TUBE, SHER-I-BRONCH, LS, 35 FR |
| Generic Name | TUBE, TRACHEAL/BRONCHIAL, DIFF |
| Product Code | CBI |
| Date Received | 2019-10-22 |
| Returned To Mfg | 2019-10-17 |
| Catalog Number | 5-16039 |
| Lot Number | 73H1900006 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL |
| Manufacturer Address | MORRISVILLE NC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-10-22 |