MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-03-08 for KNIFE HANDLE 3 352950 manufactured by Teleflex Medical.
[69755041]
(b)(4). The device has not been returned for investigation at this time. The manufacturer will continue to monitor and trend related events.
Patient Sequence No: 1, Text Type: N, H10
[69755042]
A different brand scalpel blade does not fit the teleflex #3 knife handle. There was no personnel or patient injury.
Patient Sequence No: 1, Text Type: D, B5
[71845790]
(b)(4). Dr was reviewed for notifications pertaining to incoming inspection, stock checks, and product returns. There is a known issue with lots d6-f6. Existing stock in on s-block pending corrective action. The device was functionally test with a miltex blade in accordance with incoming inspection requirements. One sample 352950 was received for investigation. Lot d6. No visual concerns were noted. The device does not conform to dimensional requirements. The device was functionally tested with a miltex blade in accordance with incoming inspection requirements. This is a known issue with multiple confirmed complaints. Dhr was reviewed for notifications pertaining to incoming inspection, stock checks, and product returns. There is known issue with lots d6-f6. Existing stock in on s-block pending corrective action. Corrective action is being determined. Existing stock of the affected lots have been placed on s-block pending resolution.
Patient Sequence No: 1, Text Type: N, H10
[71845791]
A different brand scalpel blade does not fit the teleflex #3 knife handle. There was no personnel or patient injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011137372-2017-00040 |
| MDR Report Key | 6388926 |
| Date Received | 2017-03-08 |
| Date of Report | 2017-02-10 |
| Date of Event | 2017-01-17 |
| Date Mfgr Received | 2017-03-13 |
| Date Added to Maude | 2017-03-08 |
| 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 | EFFIE JEFFERSON |
| Manufacturer Street | 3015 CARRINGTON MILL BLVD |
| Manufacturer City | MORRISVILLE NC 27560 |
| Manufacturer Country | US |
| Manufacturer Postal | 27560 |
| Manufacturer Phone | 9194332672 |
| Manufacturer G1 | TELEFLEX MEDICAL |
| Manufacturer Street | 3015 CARRINGTON MILL BLVD |
| Manufacturer City | MORRISVILLE NC 27560 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 27560 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KNIFE HANDLE 3 |
| Generic Name | HANDLE, SCAPEL |
| Product Code | GDZ |
| Date Received | 2017-03-08 |
| Catalog Number | 352950 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL |
| Manufacturer Address | RESEARCH TRIANGLE PARK NC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-03-08 |