MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2014-05-19 for CHIBA BIOPSY NEEDLE DCHN-22-15.0-U manufactured by Cook Inc..
[21445200]
A (b)(6) male patient with osteomyelitis/discitis and lumbar disc infection underwent fna lumbar disc space procedure on (b)(6) 2014. After the procedure, the doctor attempted to remove the chiba needle. When he pulled the needle out it was seen that approximately 1/2 of the needle remained in the patients soft tissue. Patient was taken from ct to the ir department where the needle was removed using fluoro guidance. No additional information has been provided by the reporter. Patient underwent a foreign body retrieval to remove the remaining part of needle.
Patient Sequence No: 1, Text Type: D, B5
[21575598]
(b)(4). Event is still under investigation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1820334-2014-00220 |
| MDR Report Key | 3854832 |
| Report Source | 07 |
| Date Received | 2014-05-19 |
| Date of Report | 2014-04-22 |
| Date of Event | 2014-04-18 |
| Date Facility Aware | 2014-04-18 |
| Report Date | 2014-04-22 |
| Date Mfgr Received | 2014-04-24 |
| Device Manufacturer Date | 2013-12-02 |
| Date Added to Maude | 2014-06-10 |
| 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 | RITA HARDEN, DIRECTOR |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal | 47404 |
| Manufacturer Phone | 8123392235 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CHIBA BIOPSY NEEDLE |
| Generic Name | DWO: NEEDLE, BIOPSY, CARDIOVASCULAR |
| Product Code | DWO |
| Date Received | 2014-05-19 |
| Returned To Mfg | 2014-05-06 |
| Model Number | NA |
| Catalog Number | DCHN-22-15.0-U |
| Lot Number | 4635757 |
| ID Number | NA |
| Device Expiration Date | 2018-11-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 4 MO |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK INC. |
| Manufacturer Address | BLOOMINGTON IN 47404 US 47404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-05-19 |