MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-02-03 for PERMCATH 8817748001 manufactured by Covidien Mfg Solutions S.a..
[134860070]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[134860071]
According to the reporter, during use, leakage from the exit site was observed at the junction of the hub and the catheter shaft. The catheter was explanted and replaced with a similar catheter, no leakage observed in the replacement catheter. It was also stated that the catheter was not repaired, there was no luer adapter issue, and tego was not utilized, no other devices were utilized by the device, there were no other defects or damages found on the product where the leak was observed. There was blood loss of 5ml as a result of the event. There was no patient injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009211636-2019-00020 |
| MDR Report Key | 8300595 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-02-03 |
| Date of Report | 2019-02-28 |
| Date of Event | 2019-01-03 |
| Date Mfgr Received | 2019-02-05 |
| Device Manufacturer Date | 2016-05-13 |
| Date Added to Maude | 2019-02-03 |
| 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 | LISA HERNANDEZ |
| Manufacturer Street | 15 HAMPSHIRE STREET |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 2034925563 |
| Manufacturer G1 | COVIDIEN MFG SOLUTIONS S.A. |
| Manufacturer Street | EDIFICIO B20, CALLE #2 |
| Manufacturer City | ALAJUELA 20101 |
| Manufacturer Postal Code | 20101 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PERMCATH |
| Generic Name | CATHETER, SUBCLAVIAN |
| Product Code | LFJ |
| Date Received | 2019-02-03 |
| Returned To Mfg | 2019-01-04 |
| Model Number | 8817748001 |
| Catalog Number | 8817748001 |
| Lot Number | 1613200088 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN MFG SOLUTIONS S.A. |
| Manufacturer Address | EDIFICIO B20, CALLE #2 ALAJUELA 20101 20101 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-02-03 |