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 2019-08-15 for RUSCH EZ-BLOCKER KIT MG-02770-002 manufactured by Teleflex Medical.
[154549744]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[154549745]
The complaint was reported as: "after installing the blocker during the procedure, a piece of plastic sheath was found wrapped around the blocker at the level of thecarina (internal ridge) at the time of the fibroscopy. " it was reported that the piece of sheath was removed with biopsy forceps and there was a delay in surgery. It was the physician's opinion a piece of the sheath was stuck to the tip of the catheter by "static force to end up in the carina (internal ridge)". The patient's condition was reported as "fine".
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011137372-2019-00249 |
| MDR Report Key | 8898359 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-08-15 |
| Date of Report | 2019-07-30 |
| Date of Event | 2019-05-01 |
| Date Mfgr Received | 2019-08-29 |
| Date Added to Maude | 2019-08-15 |
| 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 | 3015 CARRINGTON MILL BLVD |
| Manufacturer City | MORRISVILLE NC 27560 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 27560 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RUSCH EZ-BLOCKER KIT |
| Generic Name | EZ BLOCKER |
| Product Code | CBI |
| Date Received | 2019-08-15 |
| Catalog Number | MG-02770-002 |
| Lot Number | 645265 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL |
| Manufacturer Address | ATHLONE |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-08-15 |