MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2016-04-06 for OSTEO-SITE BONE BIOPSY NEEDLE N/A DBBN-11-10.0-M2-S manufactured by Cook Inc.
[41940585]
(b)(4). Event is currently under investigation.
Patient Sequence No: 1, Text Type: N, H10
[41940586]
As reported to customer relations: doctor was performing rip biopsy. When attempting to push the biopsy sample out of the coaxial needle, a small piece of metal was found in the sample. A section of the device did not remain inside the patient's body. The patient did not require any additional procedures due to this occurrence. According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Patient Sequence No: 1, Text Type: D, B5
[47644895]
(b)(4). Investigation/evaluation: during the course of the investigation, a review of the complaint history, quality control, instructions for use (ifu), specifications, and trends of the product was conducted. The product was returned in a used condition. The visual inspection noted that the cannula, stylet, and inner biopsy needle showed no defects. The obturator was not present. Also, a plastic sealed specimen cup containing a foreign material was present. The foreign material measured 2 mm in length. It was silver in color and appeared metallic. The ifu informs user of intended use, precautions, and instructions for use. A definitive root cause could not be determined. We will continue to monitor for similar complaints. Per the quality engineering risk assessment (qera) no further action is required.
Patient Sequence No: 1, Text Type: N, H10
[47644896]
As reported to customer relations: doctor was performing rip biopsy. When attempting to push the biopsy sample out of the coaxial needle, a small piece of metal was found in the sample. A section of the device did not remain inside the patient's body. The patient did not require any additional procedures due to this occurrence. According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2016-00207 |
| MDR Report Key | 5549687 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2016-04-06 |
| Date of Report | 2016-03-10 |
| Date of Event | 2016-03-04 |
| Date Facility Aware | 2016-03-04 |
| Date Mfgr Received | 2016-03-14 |
| Device Manufacturer Date | 2015-09-25 |
| Date Added to Maude | 2016-04-06 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. RITA HARDEN |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal | 47404 |
| Manufacturer Phone | 8128294891 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OSTEO-SITE BONE BIOPSY NEEDLE |
| Generic Name | DWO NEEDLE, BIOPSY, CARDIOVASCULAR |
| Product Code | DWO |
| Date Received | 2016-04-06 |
| Model Number | N/A |
| Catalog Number | DBBN-11-10.0-M2-S |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 6 MO |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK INC |
| Manufacturer Address | 750 DANIELS WAY BLOOMINGTON IN 47404 US 47404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-04-06 |