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 2019-12-11 for MAHURKAR 8888135191 manufactured by Covidien Mfg Solutions S.a..
[180461643]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[180461644]
According to the reporter, post dialysis, it was noted that there was blood leak at the transparent silica gel hose (extension tube). It was stated that the catheter was not repaired, tego was not utilized, there was no luer adapter issue and no cleaning agent was used on the device. There was no reported patient injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009211636-2019-00266 |
| MDR Report Key | 9453262 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-12-11 |
| Date of Report | 2020-02-25 |
| Date of Event | 2019-11-26 |
| Date Mfgr Received | 2020-02-12 |
| Device Manufacturer Date | 2019-01-22 |
| Date Added to Maude | 2019-12-11 |
| 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 | 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 | 2019-12-11 |
| Returned To Mfg | 2019-12-26 |
| Model Number | 8888135191 |
| Catalog Number | 8888135191 |
| Lot Number | 1831100168 |
| 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 | 2019-12-11 |