MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-04-25 for CLICK N CLOSE DYND30382 manufactured by Medline Industries - Dynacor.
[73612201]
Patient Sequence No: 1, Text Type: N, H10
[73612202]
Incorrect red blood cells (rbc) reported in urine microscopic due to urine containers that falsely elevate the count. The residents inquired to the lab about the high rbc count in urine results. The urine container contains silicone around the rim supposedly that was for easier placement of the lid on the urine container. Unfortunately the silicone gets into the urine, causing artifacts that resemble rbcs. These can be picked up while manually looking at microscopic urine but for automated equipment such as the iricell 1500 by beckman-coulter the silicone nodules falsely elevate the rbc count on automated equipment in urine samples. When we initially called in beckman-coulter because we thought there were issues with the equipment they specifically told us at that time to not use medline products because of the silicone interference.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6518933 |
| MDR Report Key | 6518933 |
| Date Received | 2017-04-25 |
| Date of Report | 2017-04-11 |
| Date of Event | 2017-03-19 |
| Report Date | 2017-04-11 |
| Date Reported to FDA | 2017-04-11 |
| Date Reported to Mfgr | 2017-04-11 |
| Date Added to Maude | 2017-04-25 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CLICK N CLOSE |
| Generic Name | CONTAINER, SPECIMEN, NON-STERILE |
| Product Code | NNI |
| Date Received | 2017-04-25 |
| Model Number | DYND30382 |
| Device Availability | * |
| Device Age | 1 DY |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES - DYNACOR |
| Manufacturer Address | 1204 TOWNLINE RD. 1 MEDLINE PLACE MUNDELEIN IL 60060 US 60060 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-04-25 |