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 2017-05-30 for PALINDROME UNK DY manufactured by Covidien Mfg Solutions S.a..
[76159884]
Submit date: 2017/may/30. An investigation is currently underway; upon completion the results will be forwarded. A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[76159885]
It was reported to covidien on (b)(6) 2017 that a customer had an issue with a dialysis catheter. The customer states in the seventh week after insertion the patient returned to the facility for dialysis and the nurse found the catheter was freely moving in and out of the entry site.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009211636-2017-05145 |
| MDR Report Key | 6597726 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-05-30 |
| Date of Report | 2017-05-03 |
| Date Mfgr Received | 2017-05-03 |
| Date Added to Maude | 2017-05-30 |
| 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 | EDWARD ALMEIDA |
| Manufacturer Street | 15 HAMPSHIRE STREET |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5084524151 |
| Manufacturer G1 | COVIDIEN MFG SOLUTIONS S.A. |
| Manufacturer Street | EDIFICIO B20, CALLE #2 |
| Manufacturer City | ALAJUELA 0101 |
| Manufacturer Postal Code | 0101 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PALINDROME |
| Generic Name | CATHETER, PERITONEAL DIALYSIS, SINGLE USE |
| Product Code | FKO |
| Date Received | 2017-05-30 |
| Model Number | UNK DY |
| Catalog Number | UNK DY |
| Lot Number | UNKNOWN |
| 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 0101 0101 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-05-30 |