MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-12-18 for * DYND11708 manufactured by Medline Industries, Inc..
[5289674]
Stylet was not removed from 8fr urinary catheter following insertion. Patient was subsequently transferred for pediatric trauma services and reported penile discomfort. On exam the retained stylet was noted within the lumen of the catheter and removed. There was no patient harm. Rn who inserted catheter prior to transfer confirmed easy catheter insertion with immediate urine return and explained that they were not aware that there was a stylet pre-inserted in this catheter. Product packaging reviewed and description does not include information about stylet.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 4377195 |
| MDR Report Key | 4377195 |
| Date Received | 2014-12-18 |
| Date of Report | 2014-12-18 |
| Date of Event | 2014-10-31 |
| Report Date | 2014-12-18 |
| Date Reported to FDA | 2014-12-18 |
| Date Reported to Mfgr | 2015-01-02 |
| Date Added to Maude | 2015-01-02 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | * |
| Generic Name | FOLEY CATHETER |
| Product Code | NWR |
| Date Received | 2014-12-18 |
| Model Number | * |
| Catalog Number | DYND11708 |
| Lot Number | 1012022340 |
| ID Number | * |
| Operator | NURSE |
| Device Availability | N |
| Device Age | 1 DA |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES, INC. |
| Manufacturer Address | ONE MEDLINE PLACE MUNDELEIN IL 60060 US 60060 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-12-18 |