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 2020-01-23 for MAHURKAR 8888135162 manufactured by Covidien Mfg Solutions S.a..
[176033726]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[176033727]
According to the reporter, during insertion, the guidewire was fine but there was a resistance when withdrawing and it became uncurl. They had to withdraw the guidewire with the catheter too. It was also stated that the catheter was not repaired and there was no leak. Tego was not utilized and there was no luer adapter issue. The insertion site was treated prior to product placement and chlorhexidine was used as cleaning agent for the device. They had to change the insertion site to insert a new catheter as medical intervention done to the patient and to resolve the issue. The treatment was proceeded and completed. The guidewire was all intact when it was removed and post x-ray was done.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009211636-2020-00021 |
| MDR Report Key | 9621390 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-01-23 |
| Date of Report | 2020-03-09 |
| Date of Event | 2020-01-08 |
| Date Mfgr Received | 2020-02-21 |
| Device Manufacturer Date | 2018-09-13 |
| Date Added to Maude | 2020-01-23 |
| 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 ST. |
| 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 | MAHURKAR |
| Generic Name | CATHETER, HEMODIALYSIS, NON-IMPLANTED |
| Product Code | MPB |
| Date Received | 2020-01-23 |
| Model Number | 8888135162 |
| Catalog Number | 8888135162 |
| Lot Number | 1822600140 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 1. Required No Informationntervention | 2020-01-23 |