MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-02-28 for ASK-29803-BKA manufactured by Teleflex Incorporated (arrow).
[101134172]
Patient Sequence No: 1, Text Type: N, H10
[101134173]
This was from the micu nurse coordinator: the doctor involved did not know the single lumen infusion catheter (slic) was in place and when the md cut the cordis to switch it over, to a central line. The slic was left in the patient and not realized until the next day during xray. The patient went to ir and had the slic snared in order to remove it. The slic cap end is blue and not labeled as a slic. The caps that are involved in this kit are too similar in appearance. There are two other pieces that look exactly the same and one is a cap and the other is a cap that has an internal extension/tail. The caps should have words indicating what they are, and the colors need to be different, so much so that those that are color blind can see the difference. (a color blind person was not involved-just for added safety). This was from the micu nurse manager: there is no way to disconnect tubing from the slic hub without opening up to air. The process for csu is to pull the whole slic out upon discontinuing and do not change the tubing. If staff is unaware of this process and the micu had tubing that needed to be changed (which happens frequently), they would naturally just change it at the hub and unknowingly open the port to air. My recommendation would be to have an extension on the slic that has tubing that can be clamped that is external to the patient like the central lines we currently have.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7302220 |
| MDR Report Key | 7302220 |
| Date Received | 2018-02-28 |
| Date of Report | 2018-02-13 |
| Date of Event | 2018-01-18 |
| Report Date | 2018-01-18 |
| Date Reported to FDA | 2018-01-18 |
| Date Reported to Mfgr | 2018-01-18 |
| Date Added to Maude | 2018-02-28 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | PERCUTANEOUS SHEATH INTRODUCER KIT |
| Product Code | OFL |
| Date Received | 2018-02-28 |
| Catalog Number | ASK-29803-BKA |
| Lot Number | NA |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX INCORPORATED (ARROW) |
| Manufacturer Address | 11245 N DISTRIBUTION COVE OLIVE BRANCH MS 38654 US 38654 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-02-28 |