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..
[134717966]
The product sample or additional supporting materials from the account was not available for this incident. Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture. There were no assembly or component issues identified. Without the physical product, a definitive root cause could not be identified. Post market vigilance will continue to monitor this condition for future potential action. Should new information become available, the file will be re-opened and the investigation will be amended as appropriate. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[134717967]
According to the reporter, during treatment, blood leak was noted coming from the connection of the arterial (red) connector and the extension tube. Then after a few weeks, while checking for permeability of the catheter, the venous (blue) had the same issue. It was stated that the connector was changed with the repair kit, distal connectors were changed and iv antibiotics was given as an intervention. It was stated that catheter was 1 year old. There was no reported patient injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009211636-2019-00016 |
| MDR Report Key | 8293496 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-01-31 |
| Date of Report | 2019-03-15 |
| Date of Event | 2018-12-14 |
| Date Mfgr Received | 2019-02-21 |
| Device Manufacturer Date | 2016-10-15 |
| 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 | 1628800104 |
| 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 |