MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,08 report with the FDA on 2006-04-24 for BIOFLEX TESIO CATHETER BFR1035KD-A manufactured by Medcomp.
[20515010]
"during the regular site care, the nurse noticed the catheter had been cracked. " the device was removed. No blood loss or pt injury reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2518902-2006-00018 |
| MDR Report Key | 705492 |
| Report Source | 01,08 |
| Date Received | 2006-04-24 |
| Date of Report | 2006-04-21 |
| Date of Event | 2006-03-04 |
| Date Mfgr Received | 2006-03-27 |
| Device Manufacturer Date | 2005-07-01 |
| Date Added to Maude | 2006-05-01 |
| 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 | 0 |
| Manufacturer Contact | SUSAN SMITH, RN |
| Manufacturer Street | 1499 DELP DRIVE |
| Manufacturer City | HARLEYSVILLE PA 19438 |
| Manufacturer Country | US |
| Manufacturer Postal | 19438 |
| Manufacturer Phone | 2152564201 |
| Manufacturer G1 | MEDCOMP |
| Manufacturer Street | 1499 DELP DRIVE |
| Manufacturer City | HARLEYSVILLE PA 19438 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 19438 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BIOFLEX TESIO CATHETER |
| Generic Name | HEMODIALYSIS CATHETER |
| Product Code | LFG |
| Date Received | 2006-04-24 |
| Model Number | BFR1035KD-A |
| Catalog Number | BFR1035KD-A |
| Lot Number | MACD680 |
| ID Number | NA |
| Device Expiration Date | 2010-07-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 694559 |
| Manufacturer | MEDCOMP |
| Manufacturer Address | * HARLEYSVILLE PA * US |
| Baseline Brand Name | 10F BIOFLEX TESIO KIT |
| Baseline Generic Name | HEMODIALYSIS CATHETER |
| Baseline Model No | NA |
| Baseline Catalog No | BFR1035KD-A |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2006-04-24 |