MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2003-10-06 for HEMOSPLIT CATHETER UNK manufactured by *.
[330902]
Pt was at dialysis unit and while removing the cap to start the treatment they noticed both hubs were cracked. Pt went to hospital to have catheter repaired.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1720496-2003-00196 |
| MDR Report Key | 491076 |
| Report Source | 07 |
| Date Received | 2003-10-06 |
| Date Added to Maude | 2003-10-27 |
| 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 | MR NITIN PATIL, MGR |
| Manufacturer Street | 5425 WEST AMELIA EARHART DR |
| Manufacturer City | SALT LAKE CITY UT 84116 |
| Manufacturer Country | US |
| Manufacturer Postal | 84116 |
| Manufacturer Phone | 8015950700 |
| Manufacturer G1 | UNK |
| Manufacturer Street | UNK |
| Manufacturer City | UNK |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HEMOSPLIT CATHETER |
| Generic Name | IMPLANTED BLOOD ACCESS DEVICE |
| Product Code | FJT |
| Date Received | 2003-10-06 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | I |
| Device Sequence No | 1 |
| Device Event Key | 479793 |
| Manufacturer | * |
| Manufacturer Address | * * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2003-10-06 |