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 PALINDORME UNK DY manufactured by Covidien Manuf. Solutions Sa.
[76138011]
Submit date: 2017/may/30. An investigation is currently underway; upon completion the results will be forwarded.
Patient Sequence No: 1, Text Type: N, H10
[76138012]
It was reported to covidien on (b)(6) 2017 that a customer had an issue with a dialysis catheter. The customer states 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 | 3009211636-2017-05140 |
| MDR Report Key | 6597384 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-05-30 |
| Date of Report | 2017-06-19 |
| Date Mfgr Received | 2017-06-19 |
| 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 ST |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5084524151 |
| Manufacturer G1 | COVIDIEN MANUF. SOLUTIONS SA |
| Manufacturer Street | EDIFICIO 820 CALLE#2 ZONA FRANCA COYOL |
| Manufacturer City | ALAJUELA 20101 |
| Manufacturer Postal Code | 20101 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PALINDORME |
| Generic Name | CATHETER, PERITONEAL DIALYSIS, SINGLE USE |
| Product Code | FKO |
| Date Received | 2017-05-30 |
| Returned To Mfg | 2017-06-19 |
| Model Number | UNK DY |
| Catalog Number | UNK DY |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN MANUF. SOLUTIONS SA |
| Manufacturer Address | EDIFICIO 820 CALLE#2 ZONA FRANCA COYOL ALAJUELA 20101 20101 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-05-30 |