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.
[4056055]
It was reported that a triple lumen bard 5f picc line secured with securacath developed a leak during use.
Patient Sequence No: 1, Text Type: D, B5
[11557158]
On (b)(4) 2013 a box was received containing the catheter that had the leak. 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 grey lumen in the catheter leaked. A rupture in the catheter could also visibly be seen starting at the 2. 5 cm mark. The rupture was approximately 0. 5 cm in length. 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 wit ha gold/palladium alloy prior to viewing under an electron microscope to increase the resolution of the fracture surface. Under the sem there was no evidence found of any deformation or any other type of damage that could have been caused by the securacath that would lead to the catheter rupture. It is unknown why the rupture occurred.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007795799-2013-00011 |
| MDR Report Key | 3573798 |
| 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 | 2014-02-20 |
| 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 | MINNEAPOLIS MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2013-10-07 |