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 2019-11-14 for HUDSON ET TUBE, SHER-I-BRONCH, LS, 37 FR 5-16037 manufactured by Teleflex Medical.
[170076216]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[170076217]
Customer reported upon opening package the "connection of angle connector" was found broken off. Issue detected prior to use. No patient involvement reported.
Patient Sequence No: 1, Text Type: D, B5
[170558856]
Qn# (b)(4). The customer returned one unit 5-16037 et tube, sher-i-bronch, ls, 37 fr for investigation. The sher-i-bronch tube and two suction catheters were returned unopened in their original packaging. The double swivel valve assembly (tracheal/bronchial swivel valves) and the y connector were also returned with the packaging. The returned sample was visually examined with and without magnification. Visual examination of the returned sample revealed that the connector on the bronchial side of the swivel valve was broken. The swivel valve is a component purchased from a supplier. A device history record review was performed and no relevant findings were identified. The reported complaint of "angle connector broke off" was confirmed based on the sample received. The connector on the bronchial side of the swivel valve was broken. The swivel valve is a component purchased from a supplier. A non-conformance has been opened to further investigate this issue.
Patient Sequence No: 1, Text Type: N, H10
[170558857]
Customer reported upon opening package the "connection of angle connector" was found broken off. Issue detected prior to use. No patient involvement reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003898360-2019-01370 |
| MDR Report Key | 9323320 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-11-14 |
| Date of Report | 2019-10-28 |
| Date of Event | 2019-10-01 |
| Date Mfgr Received | 2019-10-28 |
| Device Manufacturer Date | 2018-07-31 |
| Date Added to Maude | 2019-11-14 |
| 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, 37 FR |
| Generic Name | TUBE, TRACHEAL/BRONCHIAL, DIFF |
| Product Code | CBI |
| Date Received | 2019-11-14 |
| Returned To Mfg | 2019-11-04 |
| Catalog Number | 5-16037 |
| Lot Number | 73G1800931 |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL |
| Manufacturer Address | MORRISVILLE NC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-11-14 |