MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,other report with the FDA on 2018-04-10 for ACHIEVE NEEDLE BIOPSY TIS 16GX11CM CA1611 manufactured by Carefusion, Inc.
[104883266]
(b)(4) follow up submission will be completed post investigation or if additional information becomes available.
Patient Sequence No: 1, Text Type: N, H10
[104883267]
(firing mode)? D? Was pressed outside of the breast. When? A? Was pressed in the breast there was still a throw. Spoke with reporter via telephone and she states "the needle extended beyond the depth it is intended. " sample was obtained. Patient developed a small pneumothorax. No additional medical intervention required, resolved within one week without further complication. Three (3) needles were used that day, unsure of which one was used in this instance, all three will be returned. Additional information: (b)(6) female with small body habitus had right breast biopsy under ultrasound guidance. Coaxial and device were checked for compatibility prior to procedure, thus used during procedure. Same day chest x-ray was performed to confirm pneumothorax.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9680904-2018-00008 |
| MDR Report Key | 7412400 |
| Report Source | CONSUMER,OTHER |
| Date Received | 2018-04-10 |
| Date of Report | 2018-05-04 |
| Date of Event | 2018-02-23 |
| Date Mfgr Received | 2018-03-28 |
| Device Manufacturer Date | 2017-08-08 |
| Date Added to Maude | 2018-04-10 |
| 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 | BDX ANNA WEHRHEIM |
| Manufacturer Street | 75 N. FAIRVIEW DRIVE |
| Manufacturer City | VERNON HILLS IL 60061 |
| Manufacturer Country | US |
| Manufacturer Postal | 60061 |
| Manufacturer G1 | CAREFUSION, INC |
| Manufacturer Street | ZONA FRANCA LAS AMERICAS |
| Manufacturer City | SANTO DOMINGO |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACHIEVE NEEDLE BIOPSY TIS 16GX11CM |
| Generic Name | BIOPSY NEEDLES & TRAYS |
| Product Code | GDF |
| Date Received | 2018-04-10 |
| Catalog Number | CA1611 |
| Lot Number | 0001138553 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION, INC |
| Manufacturer Address | ZONA FRANCA LAS AMERICAS SANTO DOMINGO |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-04-10 |