MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-05-02 for FLEXIMA APDL 30935 manufactured by Boston Scientific Corporation.
[143845015]
Date of event was not provided. On (b)(6) 2019 was selected as it is the first day of the aware date month.
Patient Sequence No: 1, Text Type: N, H10
[143845016]
It was reported that the catheter drainage hub broke at the chest. The target area was located in the right lower lobe. A flexima apdl drainage catheter was selected for use. During the procedure, it was noted that the hub broke. The physician tried to remove the rube without unlocking the pigtail. Furthermore, there was leak noted in the bed. No patient complications were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2019-04694 |
| MDR Report Key | 8573760 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-05-02 |
| Date of Report | 2019-05-15 |
| Date of Event | 2019-03-13 |
| Date Mfgr Received | 2019-05-02 |
| Date Added to Maude | 2019-05-02 |
| 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 | SONALI ARANGIL |
| Manufacturer Street | TWO SCIMED PLACE |
| Manufacturer City | MAPLE GROVE MN 55311 |
| Manufacturer Country | US |
| Manufacturer Postal | 55311 |
| Manufacturer Phone | 6515827403 |
| Manufacturer G1 | BOSTON SCIENTIFIC DE COSTA RICA S.R.L. |
| Manufacturer Street | 2546 CALLE PRIMERA PROPARK, COYOL |
| Manufacturer City | ALAJUELA |
| Manufacturer Country | CS |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FLEXIMA APDL |
| Generic Name | TUBE, DRAINAGE, SUPRAPUBIC |
| Product Code | FFA |
| Date Received | 2019-05-02 |
| Model Number | 30935 |
| Catalog Number | 30935 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Address | TWO SCIMED PLACE MAPLE GROVE MN 55311 US 55311 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-02 |