MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-01-19 for MEDICOMP PORT CT IMPLANT (SILICONE) 9.6 FR manufactured by Medicomp.
[2515732]
On (b)(6) 2012, (b)(6) year old female receiving chemotherapy via mediport. Staff attempted to flush mediport before chemo administration. Pt experienced pain at site and fluid seen around hub at insertion site. Dye study revealed mediport had separated/ruptured internally. Vascular surgeon able to remove tip of catheter from pt's pulmonary artery was vascular catheterization.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5023936 |
| MDR Report Key | 2428361 |
| Date Received | 2012-01-19 |
| Date of Report | 2012-01-19 |
| Date of Event | 2012-01-03 |
| Date Added to Maude | 2012-01-27 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MEDICOMP PORT CT IMPLANT (SILICONE) 9.6 FR |
| Generic Name | MEDIPORT 9.6F MS DIGNITY CT PORT |
| Product Code | GBW |
| Date Received | 2012-01-19 |
| Lot Number | MBFT860 |
| Device Expiration Date | 2016-07-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDICOMP |
| Manufacturer Address | 1499 DELP DRIVE HARLEYSVILLE PA 19438 US 19438 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2012-01-19 |