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 2020-03-23 for HUDSON ET TUBE, SHER-I-BRONCH, LS, 39 FR 5-16039 manufactured by Teleflex Medical.
[184621977]
(b)(4). Complaint verification testing could not be performed as no sample was returned for analysis. Part number reported is not being manufactured currently, however, another part number from the same family was used for the "verification of failure mode reported in the current manufacturing process" and was conducted as follows: 80 samples were taken from the current production; the samples were visually inspected and the issue reported was not observed in the current manufacturing process. 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
[184621978]
Customer reported the connector was found "cracked upon hooking up to patient". The patient was reported to be "fine" and a new device was used.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003898360-2020-00307 |
| MDR Report Key | 9867022 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2020-03-23 |
| Date of Report | 2020-03-09 |
| Date of Event | 2020-03-03 |
| Date Mfgr Received | 2020-03-09 |
| Date Added to Maude | 2020-03-23 |
| 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 | VICTORIA SANDLIN |
| Manufacturer Street | 3015 CARRINGTON MILL BLVD |
| Manufacturer City | MORRISVILLE NC 27560 |
| Manufacturer Country | US |
| Manufacturer Postal | 27560 |
| 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, 39 FR |
| Generic Name | TUBE, TRACHEAL/BRONCHIAL, DIFF |
| Product Code | CBI |
| Date Received | 2020-03-23 |
| Catalog Number | 5-16039 |
| Lot Number | 73H1900380 |
| Device Availability | Y |
| 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 | 2020-03-23 |