MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2010-07-15 for PC PALIND EMERALD 23/40KIT VT 8888145069 manufactured by Covidien.
[1367559]
It was reported to covidien on (b)(6) 2010 that a customer had an issue with a hemodialysis catheter. The customer reports the doctor was inserting a palindrome pre-curved catheter. He inserted the flow guard (after activating the membrane in the flow guard) into the right internal jugular vein. When the dilator was removed from the flow guard, the flow guard membrane allegedly did not work and pt lost 200cc of blood. Physician used manual pressure to stop the bleeding, then proceeded to insert the catheter and complete the procedure.
Patient Sequence No: 1, Text Type: D, B5
[8610632]
Submit date: (b)(4) 2010. An investigation is currently underway. Upon completion, the results will be forwarded.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1317749-2010-00191 |
| MDR Report Key | 1765984 |
| Report Source | 01,05,06 |
| Date Received | 2010-07-15 |
| Date of Report | 2010-07-12 |
| Date of Event | 2010-07-05 |
| Report Date | 2010-07-12 |
| Date Reported to Mfgr | 2010-07-12 |
| Date Mfgr Received | 2010-07-12 |
| Date Added to Maude | 2010-11-17 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 3 |
| Manufacturer Contact | JUDITH SHAW, RN |
| Manufacturer Street | 15 HAMPSHIRE ST |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5084524151 |
| Manufacturer G1 | COVIDIEN |
| Manufacturer Street | 5439 STATE ROUTE 40 |
| Manufacturer City | ARGYLE NY 12809 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 12809 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PC PALIND EMERALD 23/40KIT VT |
| Generic Name | HEMODIALYSIS CATHETER |
| Product Code | NYU |
| Date Received | 2010-07-15 |
| Model Number | 8888145069 |
| Catalog Number | 8888145069 |
| Lot Number | 004709 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | 5439 STATE ROUTE 40 ARGYLE NY 12809 US 12809 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-07-15 |