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 5-16035 manufactured by Teleflex Medical.
[169879341]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[169879342]
Customer reported the tracheal connection broke off of the y piece while the endobronchial tube was placed in the patient. It was reported the physician "had another tube in the room which made for an easy exchange". No patient harm reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003898360-2019-01240 |
| MDR Report Key | 9217956 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2019-10-22 |
| Date of Report | 2019-09-30 |
| Date of Event | 2019-08-06 |
| Date Mfgr Received | 2019-10-22 |
| Device Manufacturer Date | 2019-02-13 |
| 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 |
| Catalog Number | 5-16035 |
| Lot Number | 73B1900372 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 |