MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2013-10-07 for SECURACATH 400110 manufactured by Interrad Medical.
[4057025]
It was reported that a dual lumen bard 5f picc line secured with securacath had a "piercing" in icu.
Patient Sequence No: 1, Text Type: D, B5
[11425574]
On (b)(6) 2013, a box was received containing the catheter that had the piercing. The securacath device used was not returned. The catheter was disinfected with cidex solution by flushing the lumens and then submerging it in the solution. During flushing, it was confirmed that the red lumen in the catheter leaked. A ruptured in the catheter could also visibly be seen starting at the -2 cm mark and extending just past the 3 cm mark. Once the catheter was disinfected the ruptured section was cut out from the catheter and taken to a materials evaluation lab for analysis. The catheter section was coated with a gold/palladium alloy prior to viewing under an electron microscope to increase the resolution of the fracture surface. The analysis showed evidence of the shaft lock on the securacath device. Instead, the catheter was pinched between the cover and base of the device. Per the securacath ifu, clinicians are instructed to verify that the catheter is in the center channel prior to snapping on the cover.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007795799-2013-00010 |
| MDR Report Key | 3573836 |
| Report Source | 07 |
| Date Received | 2013-10-07 |
| Date of Report | 2013-10-04 |
| Date of Event | 2013-09-11 |
| Date Mfgr Received | 2013-09-11 |
| Date Added to Maude | 2014-02-21 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Street | 181 CHESHIRE LN N SUITE 100 |
| Manufacturer City | MINNEAPOLIS 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 | SECURACATH |
| Product Code | OKC |
| Date Received | 2013-10-07 |
| Model Number | 400110 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTERRAD MEDICAL |
| Manufacturer Address | PLYMOUTH MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2013-10-07 |