MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,other report with the FDA on 2018-03-08 for TEMNO NEEDLE BIOPSY 22GX15CM ADJ COAXIAL ACT2215 manufactured by Carefusion, Inc.
[101888107]
(b)(4). A follow up submission will be done upon completion of carefusion's investigation or additional information becomes available.
Patient Sequence No: 1, Text Type: N, H10
[101888108]
It was reported verbally via telephone call: during a lung biopsy the needle would not go through the introducer. The physician had to stick the patient twice. Patient did develop a pneumothorax but physician felt it could have been related to the patient coughing during the procedure. Procedure was completed using a second needle. Per reporter, no additional information will be provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9680904-2018-00007 |
| MDR Report Key | 7324156 |
| Report Source | CONSUMER,OTHER |
| Date Received | 2018-03-08 |
| Date of Report | 2018-04-03 |
| Date of Event | 2018-02-13 |
| Date Mfgr Received | 2018-02-14 |
| Device Manufacturer Date | 2016-07-05 |
| Date Added to Maude | 2018-03-08 |
| 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 | TEMNO NEEDLE BIOPSY 22GX15CM ADJ COAXIAL |
| Generic Name | BIOPSY NEEDLES & TRAYS |
| Product Code | GDF |
| Date Received | 2018-03-08 |
| Catalog Number | ACT2215 |
| Lot Number | 0000965342 |
| Operator | PHYSICIAN |
| 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 | 2018-03-08 |