MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2013-03-27 for OSGOOD BIOPSY NEEDLE 7557 manufactured by Cadence In.
[18528641]
On (b)(6) 2012, during a bone marrow biopsy procedure, the needle bent the first time it was used. It was also reported that two other similar cadence needle devices used during this procedure also bent when used for the first time. Three attempts have been made to receive add'l info about the incident, but none has been received to date. If further info is received, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: D, B5
[18680622]
Cadence acknowledges this report does not meet the thirty day reporting requirement. This was unintentional. This report is being filed after it was identified as non-compliant during an internal review of our complaint files. While the actual device was not returned for eval, the reported needle bent was confirmed by photographic evidence. The cause of the needle bent could not be determined from the photograph.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1213649-2013-00006 |
| MDR Report Key | 3029303 |
| Report Source | 08 |
| Date Received | 2013-03-27 |
| Date of Report | 2012-03-21 |
| Date of Event | 2012-03-21 |
| Date Mfgr Received | 2012-03-21 |
| Device Manufacturer Date | 2011-04-05 |
| Date Added to Maude | 2013-05-28 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | ROBERT TRAHAN |
| Manufacturer Street | 2080 PLAINFIELD PIKE |
| Manufacturer City | CRANSTON RI 02921 |
| Manufacturer Country | US |
| Manufacturer Postal | 02921 |
| Manufacturer Phone | 4019421031 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OSGOOD BIOPSY NEEDLE |
| Generic Name | NEEDLE |
| Product Code | DWO |
| Date Received | 2013-03-27 |
| Model Number | 7557 |
| Catalog Number | 7557 |
| Lot Number | 75153-02 |
| 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 | CADENCE IN |
| Manufacturer Address | 2080 PLAINFIELD PIKE CRANSTON RI 02921 US 02921 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-03-27 |