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 2019-12-28 for RUSCH EB ROBERTSHAW LEFT 39F 116100390 manufactured by Teleflex Medical.
[183725797]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[183725798]
End user reported that the device "arrived cracked - leak noticed - then completely broke off. " double lumen tube adapter broken at the circuit/adapter junction. No patient involvement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8040412-2019-00368 |
| MDR Report Key | 9528314 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2019-12-28 |
| Date of Report | 2019-12-04 |
| Date of Event | 2019-11-04 |
| Date Mfgr Received | 2020-01-10 |
| Device Manufacturer Date | 2019-07-12 |
| Date Added to Maude | 2019-12-28 |
| 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 SDN. BHD. |
| Manufacturer Street | LOT NO : PT2577 JALEN PERUSAHAAN 4 KAMUNTING INDUSTRIAL ESTATE |
| Manufacturer City | PERAK, WEST MALAYSIA 34600 |
| Manufacturer Country | MY |
| Manufacturer Postal Code | 34600 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RUSCH EB ROBERTSHAW LEFT 39F |
| Generic Name | TUBE, BRONCHIAL W/WO CONNECTOR |
| Product Code | CBI |
| Date Received | 2019-12-28 |
| Returned To Mfg | 2019-12-10 |
| Catalog Number | 116100390 |
| Lot Number | UNKNOWN |
| 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 | ATHLONE |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-12-28 |