MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2018-03-26 for PALINDROME 8888145046P manufactured by Covidien Mfg Solutions S.a..
[103536902]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[103536903]
According to the reporter, during procedure, the stylet broke off in the catheter? S lumen at the proximal part. The catheter was removed and replaced by another catheter. The patient? S new catheter worked, but during the second insertion of the stylet, the physician stated that it was also difficult to remove, the material of the stylet was stretched and almost broke off as well. The piece that broke off in the lumen within the catheter was removed from the patient and nothing was left behind. There was no patient injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009211636-2018-00091 |
| MDR Report Key | 7371430 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-03-26 |
| Date of Report | 2018-04-27 |
| Date of Event | 2018-03-06 |
| Date Mfgr Received | 2018-04-12 |
| Device Manufacturer Date | 2015-10-08 |
| Date Added to Maude | 2018-03-26 |
| 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 | JACQUELINE ST. PIERRE |
| Manufacturer Street | 15 HAMPSHIRE STREET |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5084524938 |
| 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 | 2018-03-26 |
| Returned To Mfg | 2018-03-27 |
| Model Number | 8888145046P |
| Catalog Number | 8888145046P |
| Lot Number | 1526000209 |
| Device Expiration Date | 2018-09-08 |
| 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 | 2018-03-26 |