MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-07-25 for HAWKINS II BLN (BREAST LOCALIZATION NEEDLE) 252050 manufactured by Argon Medical Devices Inc..
[115198971]
The investigation is on-going. A follow-up report will be submitted once the evaluation is complete.
Patient Sequence No: 1, Text Type: N, H10
[115198972]
Breast surgeons removed the device from a patient (has done this procedure with this device many time). Upon removal, noticed the hook missing. The team at the hospital are arranging a scan to see if the hook has been retained in the patient or broke off during insertion or removal.
Patient Sequence No: 1, Text Type: D, B5
[117629167]
An update from the customer states that a follow-up scan was not conducted on the patient. A review of returned product from the customer was performed. The needle was returned in two pieces and one piece of the broken wire was returned. The combined length of the needle pieces were measured to be 50mm (5cm). The piece of the wire that was returned measured 43mm (4. 3cm) in length. According to the sample investigation, the needle was most likely bent during or after the procedure. Attempts to straighten the needle caused the needle to break into two pieces. Inspection of the wire indicates that the wire was cut from one side close to the mark on the wire. Although the exact cause of the issue cannot be determined, the issue occurred due to an event during the use of the product. Since there are no attributable manufacturing or design issues, no corrective actions will be taken at this time.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1625425-2018-00080 |
| MDR Report Key | 7719922 |
| Date Received | 2018-07-25 |
| Date of Report | 2018-08-20 |
| Date of Event | 2018-06-06 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2005-01-14 |
| Device Manufacturer Date | 2017-06-07 |
| Date Added to Maude | 2018-07-25 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. GAIL SMITH |
| Manufacturer Street | 1445 FLAT CREEK ROAD |
| Manufacturer City | ATHENS TX 75751 |
| Manufacturer Country | US |
| Manufacturer Postal | 75751 |
| Manufacturer Phone | 2144368995 |
| Manufacturer G1 | ARGON MEDICAL DEVICES INC. |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | HAWKINS II BLN (BREAST LOCALIZATION NEEDLE) |
| Generic Name | BREAST LOCALIZATION NEEDLE |
| Product Code | GDM |
| Date Received | 2018-07-25 |
| Returned To Mfg | 2018-06-29 |
| Catalog Number | 252050 |
| Lot Number | 11180055 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARGON MEDICAL DEVICES INC. |
| Manufacturer Address | 1445 FLAT CREEK ROAD ATHENS TX 75751 US 75751 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-07-25 |