MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-05-28 for MAHURKAR 8888101002HP manufactured by Covidien Mfg Solutions S.a..
[146278620]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[146278621]
According to the reporter, during the placement of triple lumen quinton catheter, the insertion site was prepped with chlorhexidine and draped in standard sterile fashion. After the administration of adequate local anesthesia (lidocaine), using the high frequency linear transducer, the vessel was interrogated and ensured to be patent. Using dynamic guidance, the needle was directed toward the vessel, resulting in real time visualization of vascular needle entry. The vein was cannulated with the introducer needle as demonstrated by the return of dark red, non-pulsatile blood. A guide wire was advanced through the needle into the vein and the needle withdrawn over the wire. Ultrasound was used and verified position of the wire in the vessel. A small skin incision was made at the insertion site. The catheter insertion tract was dilated. Subcutaneous tissue was tough and skin incision expanded to facilitate dilation. After serial dilation, the central venous catheter was passed over the wire into the vein. As the guidewire was being withdrawn, there was noted resistance. The wire over the catheter was unable to be pulled out. Blood flow was noted through open port of catheter. It was attempted to pull out the catheter but met resistance. To resolve the issue, the whole catheter and wire were pulled together as a unit. The wire distal to the catheter was noted to be stripped. The complete wire was intact with j loop visible at the end however wire was stripped. The wire was saved, and compression held over r neck. Vascular ultrasound was utilized over the area without evidence of hematoma. It was also stated that a luer lock adapter was placed on all ports except blue port where the wire was exiting. It was later reported that the patient is deceased, with no cause of death provided. It is unknown at this time if the device caused or contributed to the event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009211636-2019-00132 |
| MDR Report Key | 8647355 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-05-28 |
| Date of Report | 2019-09-04 |
| Date of Event | 2019-04-11 |
| Date Mfgr Received | 2019-08-09 |
| Date Added to Maude | 2019-05-28 |
| 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 | LISA HERNANDEZ |
| Manufacturer Street | 15 HAMPSHIRE STREET |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 2034925563 |
| 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 | MAHURKAR |
| Generic Name | CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED |
| Product Code | NIE |
| Date Received | 2019-05-28 |
| Returned To Mfg | 2019-07-31 |
| Model Number | 8888101002HP |
| Catalog Number | 8888101002HP |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 1. Death | 2019-05-28 |