MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-12-03 for SECURACATH * manufactured by Interrad Medical Inc.
[4173079]
Multiple attempts were made to discontinue a peripherally inserted central catheter (picc) line. The nurse stated the problematic piece on the device was cut in two as per instructions given by the manufacturer representative. One half of the metal prongs stayed imbedded into the skin. It was observed the metal prongs that secure the device sub-dermally had imbedded quite firmly into sub dermal tissue. Every feasible angle was attempted to remove the device in a gentle fashion. The nurse said the best way to describe the process is similar to removing an implanted fish hook from skin. There have been multiple complaints from many staff regarding this particular picc removal. Experienced staff nurses were having difficulty. The manufacturer has sent out representatives for in-services since but this makes no difference in the removals. Staff has said that at times there is 'tissue' attached to the metal prongs on removal. The patient state the experience is 'horrible'.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3622136 |
| MDR Report Key | 3622136 |
| Date Received | 2013-12-03 |
| Date of Report | 2013-12-03 |
| Date of Event | 2013-11-15 |
| Report Date | 2013-12-03 |
| Date Reported to FDA | 2013-12-03 |
| Date Reported to Mfgr | 2014-02-11 |
| Date Added to Maude | 2014-02-11 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SECURACATH |
| Generic Name | CATHETER, INTRAVASCULAR CATHETER SECUREMENT |
| Product Code | OKC |
| Date Received | 2013-12-03 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | NURSE |
| Device Availability | Y |
| Device Age | 1 DAY |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTERRAD MEDICAL INC |
| Manufacturer Address | 181 CHESHIRE LANE SUITE 100 PLYMOTH MN 55441 US 55441 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-12-03 |