MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-01 for PALINDROME DIALYSIS UNKNOWN manufactured by Covidien Mfg Solutions S.a..
[143954369]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[143954370]
According to the reporter, during use, the device had fallen out of the patient by itself and had a leak at the exit site. No visible fault was seen and a new catheter was placed into the patient to resolve the issue. It was also stated that the catheter was not repaired, tego was not utilized, and there was no luer adapter issue. Clinnel wipes was used a s cleaning agent on the device. There was no patient injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009211636-2019-00112 |
| MDR Report Key | 8569672 |
| Date Received | 2019-05-01 |
| Date of Report | 2019-10-17 |
| Date of Event | 2019-04-11 |
| Date Mfgr Received | 2019-10-01 |
| Date Added to Maude | 2019-05-01 |
| 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 | KIT, REPAIR, CATHETER, HEMODIALYSIS |
| Product Code | NFK |
| Date Received | 2019-05-01 |
| Returned To Mfg | 2019-05-03 |
| Model Number | DIALYSIS UNKNOWN |
| Catalog Number | DIALYSIS UNKNOWN |
| Lot Number | 1428600093 |
| 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 | 2019-05-01 |