MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,05 report with the FDA on 2005-10-07 for HAWKINS III BLN * 243075 manufactured by Medical Device Technologies, Inc..
[514430]
Customer claims needle tip was "difficult to penetrate the skin with. "
Patient Sequence No: 1, Text Type: D, B5
[7793033]
The device is available for eval. However, the customer forwarded us a "report of product failure," with no device. We have rec'd no similar complaints in the past 3 years. A review of the device history record found no variations. Based on the report rec'd from the customer, it is our opinion that the needle tip of the device in question was damaged after leaving our facility. We 100% inspect these needle tips prior to packaging, and insert a sheath over the needle after inspection. We don't see any means by which this needle tip can be damaged with the sheath installed, and the packaging contains the sheath. Based on the above, we consider this an isolated incident.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1036710-2005-00006 |
| MDR Report Key | 767916 |
| Report Source | 00,05 |
| Date Received | 2005-10-07 |
| Date of Report | 2005-10-07 |
| Date of Event | 2005-09-30 |
| Date Mfgr Received | 2005-10-04 |
| Device Manufacturer Date | 2005-05-01 |
| Date Added to Maude | 2006-10-11 |
| 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 | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | ENGINEER |
| Manufacturer Street | 3600 SW 47TH AVE |
| Manufacturer City | GAINESVILLE FL 32608 |
| Manufacturer Country | US |
| Manufacturer Postal | 32608 |
| Manufacturer Phone | 3523380440 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HAWKINS III BLN |
| Generic Name | BREAST LOCALIZATION NEEDLE |
| Product Code | MIJ |
| Date Received | 2005-10-07 |
| Model Number | * |
| Catalog Number | 243075 |
| Lot Number | 512610SS |
| ID Number | * |
| Device Expiration Date | 2010-05-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 632791 |
| Manufacturer | MEDICAL DEVICE TECHNOLOGIES, INC. |
| Manufacturer Address | * GAINESVILLE FL 32608 US |
| Baseline Brand Name | HAWKINS III BLN |
| Baseline Generic Name | BREAST LOCALIZATION NEEDLE |
| Baseline Model No | * |
| Baseline Catalog No | 243075 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-10-07 |