MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-09-16 for PORT A CATH manufactured by Smiths Medical.
[4921695]
Port a cath fractured upon removal attempt. Patient unable to maintain stable vitals to allow for continued attempts to remove. Port a cath implanted (b)(6) 2009. Patient with leukemia required cancer therapy and lab draws. Concern that this catheter should not have fractured like it did preventing removal.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5038297 |
| MDR Report Key | 4114516 |
| Date Received | 2014-09-16 |
| Date of Report | 2014-09-16 |
| Date of Event | 2014-09-07 |
| Date Added to Maude | 2014-09-25 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 |
| Generic Name | PORT A CATH |
| Product Code | LNY |
| Date Received | 2014-09-16 |
| Operator | HEALTH PROFESSIONAL |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITHS MEDICAL |
| Manufacturer Address | ST. PAUL 55112 55112 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 2014-09-16 |