MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2019-03-26 for PALINDROME 8888145044P manufactured by Covidien Mfg Solutions S.a..
[139978754]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[139978755]
According to the reporter, when checking for the impermeability of the catheter, blood was leaking at the distal junction between the red tip and the clear (white) tubing. The catheter was repaired using a repair kit in order to resolve the issue. It was also reported that hemoculture was done and was given antibiotics at the end of treatment closing both lines with antibiotic (antibiotic lock). There was no reported patient outcome.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009211636-2019-00068 |
| MDR Report Key | 8453818 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2019-03-26 |
| Date of Report | 2019-04-17 |
| Date Mfgr Received | 2019-03-27 |
| Device Manufacturer Date | 2016-10-15 |
| Date Added to Maude | 2019-03-26 |
| 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 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 | 2019-03-26 |
| Model Number | 8888145044P |
| Catalog Number | 8888145044P |
| Lot Number | 1628800104 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2019-03-26 |