MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2014-09-02 for ACKERMANN BONE BIOPSY NEEDLE SET ABC-100 manufactured by Cook, Inc..
[4746213]
The female pt called the mfr, reporting that an incident occurred sometime in (b)(6) 2014 at a hospital; involving abc-100 bone biopsy needle. Additional info was provided stating that during the procedure, the turn handle broke off of the needle and the needle became stuck in the pt's foot. The pt said that this procedure should have lasted 45 minutes but ended up lasting over 2 hrs due to the time required to remove the broken needle from her foot. The pt said she was conscious for the entire procedure. Other doctors were brought in to help. According to the pt, the broken needle was ultimately removed from her foot during this procedure after the doctors had attempted different solutions including, pulling, grabbing, and hitting the needle with a hammer. A section of the device did not remain inside the pt's body. The pt did not require any additional procedures due to this occurrence.
Patient Sequence No: 1, Text Type: D, B5
[12330600]
Pt info not provided by the reporter. Lot number was not provided by the reporter. Exp date unk as lot is unk. Name of facility was not provided by the reporter. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1820334-2014-00414 |
| MDR Report Key | 4071239 |
| Report Source | 00 |
| Date Received | 2014-09-02 |
| Date of Report | 2014-08-08 |
| Date of Event | 2014-04-12 |
| Date Facility Aware | 2014-04-12 |
| Report Date | 2014-08-08 |
| Date Mfgr Received | 2014-08-11 |
| Date Added to Maude | 2014-09-10 |
| 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, DIR |
| 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 | ACKERMANN BONE BIOPSY NEEDLE SET |
| Generic Name | NEEDLE, BIOPSY, CARDIOVASCULAR |
| Product Code | DWO |
| Date Received | 2014-09-02 |
| Model Number | NA |
| Catalog Number | ABC-100 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2014-09-02 |