MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-02-15 for CAREFUSION 22G X 15CM ACT2215 manufactured by Carefusion.
[100425690]
During cut guided lung biopsy, md placed the introducer in the pt for a lung biopsy. The needle would not go through the introducer. Physician said it felt like there was obstruction. Needle and introducer removed. New device opened and the procedure was completed. Post procedure the pt developed a pneumothorax. The md states it may or may not be related to the defective device as the pt was also coughing during the procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5075316 |
| MDR Report Key | 7276189 |
| Date Received | 2018-02-15 |
| Date of Report | 2018-02-14 |
| Date of Event | 2018-02-13 |
| Date Added to Maude | 2018-02-16 |
| 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 |
| 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 | 0 |
| Brand Name | CAREFUSION |
| Generic Name | TEMNO BIOPSY NEEDLE |
| Product Code | IKT |
| Date Received | 2018-02-15 |
| Model Number | 22G X 15CM |
| Catalog Number | ACT2215 |
| Lot Number | 0000965342 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION |
| Manufacturer Address | US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-02-15 |