MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-09-26 for EXPEL? MULTO-PURPOSE DRAINAGE CATHETER 39311-105 manufactured by Boston Scientific Corporation.
[87385021]
Patient Sequence No: 1, Text Type: N, H10
[87385022]
Patient returned to hospital for dressing change due to leaking abscess drain placed in ir ct. The tubing and stopcock were not the source of the leak. After rt evaluated tube the leak was from the catheter hub being cracked. Patient was kept and pre procedure work done in spec procedure holding area. Dr. Ordered for drainage catheter exchange and tube was exchanged under x-ray guidance. Patient was recovered post procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6893949 |
| MDR Report Key | 6893949 |
| Date Received | 2017-09-26 |
| Date of Report | 2017-08-31 |
| Date of Event | 2017-08-03 |
| Report Date | 2017-08-31 |
| Date Reported to FDA | 2017-08-31 |
| Date Reported to Mfgr | 2017-08-31 |
| Date Added to Maude | 2017-09-26 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EXPEL? MULTO-PURPOSE DRAINAGE CATHETER |
| Generic Name | DRAINAGE CATHETER |
| Product Code | OEI |
| Date Received | 2017-09-26 |
| Returned To Mfg | 2017-08-08 |
| Model Number | 39311-105 |
| Lot Number | 20546327 |
| Device Availability | R |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Address | 100 BOSTON SCIENTIFIC WAY MARLBOROUGH MA 01752 US 01752 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-09-26 |