MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-08-28 for HUDSON ET TUBE, SHER-I-BRONCH, LS, 37 FR 5-16037 manufactured by Teleflex Medical.
[156004401]
(b)(4). Complaint verification testing could not be performed as no sample was returned for analysis. A device history record review was performed and no relevant findings were identified. A verification of failure mode reported in the current manufacturing process was conducted as follows: 140 samples were taken from the current production, the samples were inspected and the revised characteristics comply with the requirement. Without the device to evaluate, the complaint could not be confirmed and the probable cause could not be determined from the available information. Teleflex will continue to monitor and trend for reports of this nature. If the sample becomes available at a later date a follow up report will be submitted with investigation results.
Patient Sequence No: 1, Text Type: N, H10
[156004402]
It was reported that "(b)(6) 2019, (b)(6) hospital, doctor found connecter damage when opened the package prior to use on patient. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003898360-2019-01050 |
| MDR Report Key | 8942048 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-08-28 |
| Date of Report | 2019-08-09 |
| Date of Event | 2019-08-08 |
| Date Mfgr Received | 2019-09-23 |
| Device Manufacturer Date | 2018-09-12 |
| Date Added to Maude | 2019-08-28 |
| 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, 37 FR |
| Generic Name | TUBE, TRACHEAL/BRONCHIAL, DIFF |
| Product Code | CBI |
| Date Received | 2019-08-28 |
| Returned To Mfg | 2019-08-28 |
| Catalog Number | 5-16037 |
| Lot Number | 73J1800339 |
| 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 | RESEARCH TRIANGLE PARK NC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-08-28 |