MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-30 for SECURACATH 400140 manufactured by Interrad Medical.
[109764285]
Interrad medical emailed (b)(6), clinical nurse manager vascular access and nutrition (b)(6), the reporter, to gather more information about what occurred. (b)(6) stated via email that the patient was receiving chemotherapy, would have had a tagaderm dressing, and that associated materials were sent to bard in august at the time of the occurrence. Interrad medical received only the securacath device, and a letter regarding bard's conclusion to their investigation. The letter stated that the catheter broke 1. 3 cm from the strain relief of the catheter. It should be noted that placement of the securacath device abutting the strain relief would be highly atypical, as in the general practice of healthcare professionals and per training by interrad medical, the region between the strain relief and the first cm markings of the catheter (approximately 1 cm. ) would not be used to secure the catheter with the securacath. The catheter break most likely happened between the strain relief and the securacath device, completely outside the securacath device itself. Bard did not provide information as to the placement of the securacath on the catheter. An examination of the device returned to interrad medical did not observe any anomalies in the device that could have led to the catheter breaking. An analysis of a 4f single lumen groshong catheter (same type of catheter involved in this incident), gathered data on flow rates and retention forces. The analysis showed that the securacath did not significantly reduce flow and had acceptable retention forces without any fractures seen. Given a review of all of the data gathered in regards to this incident, interrad medical concludes that there is no indication that the securacath device malfunctioned or led to the catheter failure. In addition, a review of the fda maude database from (b)(6) 2017 to (b)(6) 2018 found no less than three reports of breakages for 4f single lumen groshong catheters without a securacath in use.
Patient Sequence No: 1, Text Type: N, H10
[109764286]
Interrad received information from a nurse field specialist from bard vascular access stating that "a picc line was placed on (b)(6) 2018 and secured with securacath. The line snapped and the picc was replaced". This was in regards to a complaint that they received about their catheter.
Patient Sequence No: 1, Text Type: D, B5
[117979035]
Interrad medical emailed the initial reporter, a clinical nurse of vascular access and (b)(4), to gather more information about what occurred. The initial reporter stated via email that the patient was receiving chemotherapy, would have had a tegaderm dressing, and that associated materials were sent to bard in august at the time of the occurrence. Interrad medical received only the securacath device, and a letter regarding bard's conclusion to their investigation. The letter stated that the catheter broke 1. 3 cm from the strain relief of the catheter. It should be noted that placement of the securacath device abutting the strain relief would be highly atypical, as in the general practice of healthcare professionals and per training by interrad medical, the region between the strain relief and the first cm markings of the catheter (approximately 1 cm. ) would not be used to secure the catheter with the securacath. The catheter break most likely happened between the strain relief and the securacath device, completely outside the securacath device itself. Bard did not provide information as to the placement of the securacath on the catheter. An examination of the device returned to interrad medical did not observe any anomalies in the device that could have led to the catheter breaking. An analysis of a 4f single lumen groshong catheter (same type of catheter involved in this incident), gathered data on flow rates and retention forces. The analysis showed that the securacath did not significantly reduce flow and had acceptable retention forces without any fractures seen. Given a review of all of the data gathered in regards to this incident, interrad medical concludes that there is no indication that the securacath device malfunctioned or led to the catheter failure. In addition, a review of the fda maude database from dec. 2017 to feb. 2018 found no less than three reports of breakages for 4f single lumen groshong catheters without a securacath in use.
Patient Sequence No: 1, Text Type: N, H10
[117979036]
Interrad received information from a nurse field specialist from bard vascular access stating that "a picc line was placed on (b)(6) 2018 and secured with securacath. The line snapped and the picc was replaced". This was in regards to a complaint that they received about their catheter.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007795799-2018-00001 |
| MDR Report Key | 7555596 |
| Date Received | 2018-05-30 |
| Date of Report | 2018-05-30 |
| Date Mfgr Received | 2018-04-30 |
| Date Added to Maude | 2018-05-30 |
| 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 | MR. PATRICK DECK |
| Manufacturer Street | 181 CHESHIRE LANE SUITE 100 |
| Manufacturer City | PLYMOUTH MN 55441 |
| Manufacturer Country | US |
| Manufacturer Postal | 55441 |
| Manufacturer Phone | 7634522721 |
| Manufacturer G1 | INTERRAD MEDICAL |
| Manufacturer Street | 181 CHESHIRE LANE SUITE 100 |
| Manufacturer City | PLYMOUTH MN 55441 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55441 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | SECURACATH |
| Generic Name | SECURACATH |
| Product Code | OKC |
| Date Received | 2018-05-30 |
| Returned To Mfg | 2018-05-16 |
| Model Number | 400140 |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTERRAD MEDICAL |
| Manufacturer Address | 181 CHESHIRE LANE SUITE 100 PLYMOUTH MN 55441 US 55441 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-05-30 |