MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,05 report with the FDA on 2014-03-11 for SECURACATH SCR-1 400100 manufactured by Interrad Medical Inc.
[4254522]
The risk manager at (b)(6) reported that there were reports of difficulty in removing the anchor from patient's with tissue scar adhesion around the device. The nurse(s) were trying to remove the anchor gently to avoid hurting the patient resulting in difficulty removing the anchor and discomfort for the patient. There were no device malfunction an no adverse event. This incident occurred during the early implementation phase of the device, when many clinicians were just beginning to use the device. The company has found the removal process becomes easier once experience has been obtained. On some patients, especially with longer dwell times, the anchors become more embedded in the tissue. For these cases, the anchor needs to be pulled out using a swift, deliberate tug. The small, blunt anchors straighten when pulled out without damaging the skin. The removal of securacath, when done correctly, can be equated to the removal of a huber needle from an implanted port in that some patients may experience momentary pain if any upon removal which quickly subsides upon completion of the removal procedure.
Patient Sequence No: 1, Text Type: D, B5
[11620109]
There were no device malfunction nor harm to the patient. Tissue growth around the anchor is normal and removal of the anchor under these condition is described in the ifu. A rapid deliberate tug of the anchor is required to remove the anchor from the subcutaneous space if tissue growth is present. This generally results in little or no discomfort from the patient and is preferred to the gentle tentative anchor removal.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007795799-2014-00012 |
| MDR Report Key | 3693330 |
| Report Source | 00,05 |
| Date Received | 2014-03-11 |
| Date of Report | 2014-03-03 |
| Date of Event | 2013-11-15 |
| Date Mfgr Received | 2014-02-19 |
| Date Added to Maude | 2014-03-27 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Street | 181 CHESHIRE LN N SUITE 100 |
| Manufacturer City | PLYMOUTH MN 55441 |
| Manufacturer Country | US |
| Manufacturer Postal | 55441 |
| Manufacturer Phone | 7632256699 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SECURACATH |
| Generic Name | SECUREMENT FOR INTRAVASCULAR DEVICES |
| Product Code | OKC |
| Date Received | 2014-03-11 |
| Model Number | SCR-1 |
| Catalog Number | 400100 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTERRAD MEDICAL INC |
| Manufacturer Address | 181 CHESHIRE LN SUITE 100 PLYMOUTH MN 55441 US 55441 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-03-11 |