MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2009-04-24 for HAWKINS III FLEXSTRAND BLN 10CM 253100 manufactured by Medical Device Technologies, Inc. Dba Angiotech.
[1267577]
The needle tip bent upon insertion through very dense breast tissue. Two more needles needed to be manually advanced with great force to be manually advanced with great force to penetrate dense breast tissue. The third needle was left in place, as the tip was bent and could not be removed. The patient was taken to surgery (was already scheduled to be) and the needle was removed during lumpectomy procedure.
Patient Sequence No: 1, Text Type: D, B5
[8435342]
The sample for this complaint has not been received from the customer, and there was no product left in stock of this lot to review. Our caution statement that is supplied with the product states: rapid advancement of this needle into the dense breast tissue may result in needle bending at the eyelet; advance carefully if resistance is experienced. Once we receive the sample from the customer, we will review it to ensure there is not an underlying manufacture root cause for this defect. This is the first complaint for this product line for this defect and therefore, considered an isolated incident.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1036710-2009-00004 |
| MDR Report Key | 1420197 |
| Report Source | 07 |
| Date Received | 2009-04-24 |
| Date of Report | 2009-04-22 |
| Date of Event | 2009-03-23 |
| Date Mfgr Received | 2009-03-23 |
| Device Manufacturer Date | 2008-10-01 |
| Date Added to Maude | 2009-10-23 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | SHANNON BROOKS, SR. ANALYST |
| Manufacturer Street | 3600 S.W. 47TH AVE. |
| Manufacturer City | GAINESVILLE FL 32608 |
| Manufacturer Country | US |
| Manufacturer Postal | 32608 |
| Manufacturer Phone | 3523380440 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HAWKINS III FLEXSTRAND BLN 10CM |
| Generic Name | HAWKINS BREAST LOCALIZATION NEEDLE |
| Product Code | MIJ |
| Date Received | 2009-04-24 |
| Model Number | 253100 |
| Lot Number | 82951QFE |
| Device Expiration Date | 2013-10-30 |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDICAL DEVICE TECHNOLOGIES, INC. DBA ANGIOTECH |
| Manufacturer Address | 3600 S.W. 47TH AVE. GAINESVILLE FL 32608 US 32608 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2009-04-24 |