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 2019-01-31 for PALINDROME 8888145044P manufactured by Covidien Mfg Solutions S.a..
[134742744]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[134742745]
According to the reporter, during treatment, blood leak was noted coming from the distal junction of the venous branch. It was stated that there was a break at this place. Treatment was not initiated as there was a risk of air entering the leak and pulmonary embolism. The venous branch was repaired with the repair kit and a dose of antibiotics was given as an intervention. There was no reported patient injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009211636-2019-00017 |
| MDR Report Key | 8293615 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-01-31 |
| Date of Report | 2019-04-15 |
| Date of Event | 2019-01-03 |
| Date Mfgr Received | 2019-03-26 |
| Device Manufacturer Date | 2016-05-24 |
| Date Added to Maude | 2019-01-31 |
| 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 | PALINDROME |
| Generic Name | CATHETER, HEMODIALYSIS, IMPLANTED, COATED |
| Product Code | NYU |
| Date Received | 2019-01-31 |
| Model Number | 8888145044P |
| Catalog Number | 8888145044P |
| Lot Number | 1613900109 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| 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 | 2019-01-31 |