MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2005-03-29 for MAHURKAR DUAL LUMEN CATHETER 88156680071 * manufactured by Tyco/kendall Healthcare.
[402106]
In 2005, a left femoral mahurkar (quinton) catheter was inserted. The next day @ approx 7:05am patient was found unresponsive, lying in a large amount of blood. The left femoral venous catheter was found uncapped and unclamped. Patient coded and resuscitated however died later that morning. Initial investigation did not identify a potential problem with the device; however, upon closer analysis in 3/05 of a duplicate device, the adequacy of the clamp and cap mechanism were questioned as being easily loosened or removable.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1317749-2005-00016 |
| MDR Report Key | 585668 |
| Report Source | 05,07 |
| Date Received | 2005-03-29 |
| Date of Report | 2005-03-29 |
| Date of Event | 2005-01-19 |
| Date Facility Aware | 2005-03-02 |
| Report Date | 2005-03-28 |
| Date Reported to FDA | 2005-03-28 |
| Date Reported to Mfgr | 2005-03-28 |
| Date Added to Maude | 2005-03-30 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | ADRIENNE MARCELLUS, RN |
| Manufacturer Street | 15 HAMPSHIRE ST. |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5082618441 |
| Manufacturer G1 | TYCO/KENDALL HEALTHCARE |
| Manufacturer Street | 15 HAMPSHIRE STREET |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02048 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MAHURKAR DUAL LUMEN CATHETER |
| Generic Name | HEMODIALYSIS CATHETER |
| Product Code | LFK |
| Date Received | 2005-03-29 |
| Model Number | 88156680071 |
| Catalog Number | * |
| Lot Number | UNK |
| ID Number | * |
| Device Expiration Date | 2007-05-01 |
| Device Availability | N |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 575511 |
| Manufacturer | TYCO/KENDALL HEALTHCARE |
| Manufacturer Address | 15 HAMPSHIRE STREET MANSFIELD MA 02048 US |
| Baseline Brand Name | MAHURKAR DUAL LUMEN CATHETER |
| Baseline Generic Name | HEMODIALYSIS CATHETER |
| Baseline Model No | 88156680071 |
| Baseline Catalog No | * |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2005-03-29 |