MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2019-01-17 for SECURACATH SCR-01 UNKNOWN manufactured by Interrad Medical.
[133936812]
No devices were returned and very minimal information is known about the events. No additional information has been received about the events to aid in determining what contributing factors were involved in the catheter failures. Based on what was reported, only one of the catheter failures occurred "near" the securacath, meaning the other catheter failure was away from the securacath and therefore not a contributing factor to the catheter failure. Extensive testing has been done on bard powerpiccs that shows that the securacath device does not cause leaks in catheters even when placed for extended length of time. Catheters are known to leak without the use of securacath and it is likely these catheters could have leaked without the use of securacath. Based on previous investigations, leaks occur because of extrusion/material defects in the catheter or gross misuse of the catheter. These catheter failures were likely unrelated to the use of securacath and most likely caused by extrusion/material defects in the catheter or misuse of the catheter. Multiple attempts have been made to collect more information without success. If relevant information is collected that allows for further investigation, a follow up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[133936813]
Picc line service lead informed manufacturer representative that "we have had 2 reportable picc lines with a hole in, with one near to the securacath location". The picc lines were bard powerpicc solo of unknown size.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007795799-2019-00001 |
| MDR Report Key | 8259056 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2019-01-17 |
| Date of Report | 2019-01-17 |
| Date of Event | 2018-12-17 |
| Date Mfgr Received | 2018-12-18 |
| Date Added to Maude | 2019-01-17 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | BRIAN BOSCH |
| Manufacturer Street | 181 CHESHIRE LANE SUITE 100 |
| Manufacturer City | PLYMOUTH MN 55441 |
| Manufacturer Country | US |
| Manufacturer Postal | 55441 |
| 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 | 3 |
| Brand Name | SECURACATH |
| Generic Name | SUBCUTANEOUS ENGINEERED STABILIZATION DEVICE |
| Product Code | OKC |
| Date Received | 2019-01-17 |
| Model Number | SCR-01 |
| Catalog Number | UNKNOWN |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| 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 | 2019-01-17 |