MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,other,user facility report with the FDA on 2018-06-08 for PALINDROME 8888123405P manufactured by Covidien Mfg Solutions S.a..
[110578006]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[110578007]
According to the reporter, the catheter fell out. It was stated that the tissue attenuation into the cuff seemed to be delayed or absent. The catheter was secured with sutures for an extended period of time but in this situation, it was stated that the cuff was clearly exposed. The catheter was inserted and was removed. There was no reported patient injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009211636-2018-00186 |
| MDR Report Key | 7583080 |
| Report Source | FOREIGN,OTHER,USER FACILITY |
| Date Received | 2018-06-08 |
| Date of Report | 2018-06-08 |
| Date of Event | 2016-05-02 |
| Date Mfgr Received | 2018-05-23 |
| Device Manufacturer Date | 2015-03-30 |
| Date Added to Maude | 2018-06-08 |
| 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 | 2018-06-08 |
| Model Number | 8888123405P |
| Catalog Number | 8888123405P |
| Lot Number | 1507600083 |
| Device Expiration Date | 2018-02-28 |
| 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 | 2018-06-08 |