MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,08 report with the FDA on 2012-04-19 for ACKERMANN BONE BIOPSY NEEDLE SET ABC-100 manufactured by Cook Inc.
[2752210]
End of needle broke. Spike part of needle remained stuck in child and needed a lot of force to remove. This was the second time in less than a week this occurred. No patient outcome has been provided by the reporter.
Patient Sequence No: 1, Text Type: D, B5
[9836924]
(b)(4). Event evaluation: still under investigation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1820334-2012-00202 |
| MDR Report Key | 2559711 |
| Report Source | 01,08 |
| Date Received | 2012-04-19 |
| Date of Report | 2012-03-21 |
| Date of Event | 2012-03-21 |
| Date Facility Aware | 2012-03-21 |
| Report Date | 2012-03-21 |
| Date Mfgr Received | 2012-03-22 |
| Device Manufacturer Date | 2011-12-01 |
| Date Added to Maude | 2012-05-21 |
| 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, MANAGER |
| 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 | DWO NEEDLE, BIOPSY, CARDIOVASCULAR |
| Product Code | DWO |
| Date Received | 2012-04-19 |
| Model Number | NA |
| Catalog Number | ABC-100 |
| Lot Number | F2705338 |
| ID Number | NA |
| Device Expiration Date | 2016-11-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 3 MO |
| 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 | 2012-04-19 |