MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2014-03-18 for LATEX FOLEY CATHETER, 20F DYNDT1089A manufactured by Medline Industries, Inc..
[4477463]
While urinating, a small plastic piece came out. The patient had previously had an indwelling foley catheter which was thought to be a potential source of the plastic.
Patient Sequence No: 1, Text Type: D, B5
[11887463]
A patient brought a small plastic tube to his physician's office and stated that it came out when he was urinating. There was no injury or need for medical intervention. The patient had been a previous inpatient and while hospitalized, he had an indwelling foley catheter. A photo was sent showing a translucent tube measuring approximately 3 cm in length. The diameter was not reported and the sample was not returned. We have no lot number. It is not known where the tube originated. Other than the foley, there was nothing else inserted into the patient during his hospital stay. The components in the foley kit were reviewed and there are no components that resemble the object in the photo. A root cause has not been determined. We cannot confirm the catheter caused or contributed to the reported incident. However, in an abundance of caution, this medwatch is being filed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1417592-2014-00029 |
| MDR Report Key | 3807410 |
| Report Source | 06 |
| Date Received | 2014-03-18 |
| Date of Report | 2014-03-10 |
| Date of Event | 2014-02-10 |
| Date Mfgr Received | 2014-02-11 |
| Date Added to Maude | 2014-05-14 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | JULIE FINLEY |
| Manufacturer Street | ONE MEDLINE PLACE |
| Manufacturer City | MUNDELEIN IL 60060 |
| Manufacturer Country | US |
| Manufacturer Postal | 60060 |
| Manufacturer Phone | 8476434709 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LATEX FOLEY CATHETER, 20F |
| Product Code | NWR |
| Date Received | 2014-03-18 |
| Catalog Number | DYNDT1089A |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES, INC. |
| Manufacturer Address | MUNDELEIN IL 60060 US 60060 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-03-18 |