MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-10-04 for ASPIRATION TUBING SET 72-00114-D K10002267 manufactured by Northgate Technologies, Inc..
[2289457]
Customer states, (b)(6) 2011 out of box failure. The first tubing set broke in the nurses hand, the next four (4) had the red tag on the wrong end and when they use by turning it around it is a danger to the patient per the doctor. They will have to use a couple that way as this item is on back order and they have cases.
Patient Sequence No: 1, Text Type: D, B5
[9311790]
The piece of 10' tubing that has the red flag assembled to it now has a red stripe the entire length of the 10' assembly operations shall assemble the red flag to that length of tubing and only that length of tubing. The tubing shall be wrapped and inserted into a tyvek pouch with the 10' piece of unstriped tubing on the bottom and the 10' striped tubing on the top - this way you can always tell if the red flag is assembled to the correct piece of 10' tubing. In addition, the ifu has been improved greatly to include better graphics such as the "flow," "red flag," and the piece of 10' tubing that illustrates the red stripe. Also, the ifu shall be included in each tyvek pouch.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1450997-2011-00001 |
| MDR Report Key | 2303758 |
| Report Source | 05,06 |
| Date Received | 2011-10-04 |
| Date of Report | 2011-10-03 |
| Date of Event | 2011-07-08 |
| Date Mfgr Received | 2011-07-25 |
| Device Manufacturer Date | 2010-12-01 |
| Date Added to Maude | 2012-07-06 |
| 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 Street | 1591 SCOTTSDALE COURT |
| Manufacturer City | ELGIN IL 60123 |
| Manufacturer Country | US |
| Manufacturer Postal | 60123 |
| Manufacturer Phone | 2248562222 |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | 1450997-8/4/11-001-R |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ASPIRATION TUBING SET |
| Generic Name | FLUID ASPIRATION TUBING SET |
| Product Code | KQT |
| Date Received | 2011-10-04 |
| Returned To Mfg | 2011-07-26 |
| Model Number | 72-00114-D |
| Catalog Number | K10002267 |
| Lot Number | NW9527 |
| ID Number | NA |
| Device Expiration Date | 2015-12-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NORTHGATE TECHNOLOGIES, INC. |
| Manufacturer Address | 1591 SCOTTSDALE COURT ELGIN IL 60123 US 60123 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-10-04 |