MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2014-05-23 for LATEX FOLEY CATHETER, 16F DYNDP160116 manufactured by Medline Industries, Inc..
[22002030]
The catheter balloon was not fully deflated prior to removal from the pt.
Patient Sequence No: 1, Text Type: D, B5
[22305686]
Prior to removal of the catheter, the clinician attached the syringe to the inflation pigtail and removed fluid from the balloon. As she pulled on the catheter, she felt some resistance. She continued to pull, removed the catheter and noted the balloon was not fully deflated. It is not known why the clinician did not identify a discrepancy between the volume removed from the balloon compared to the initial volume instilled. A small amount of bleeding was noted but the facility reported that no serious injury resulted and medical intervention was not indicated. The catheter was being discontinued and there was no need for it to be replaced. The sample was returned and evaluated. The catheter balloon was found to have 1-2ml of retained fluid in it. The balloon inflation lumen was collapsed near the irrigation eye within the balloon. A possible root cause for the collapsed lumen may have been the increased vacuum pressure created by the pullback on the syringe.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1417592-2014-00052 |
| MDR Report Key | 3854878 |
| Report Source | 06 |
| Date Received | 2014-05-23 |
| Date of Report | 2014-05-20 |
| Date of Event | 2014-02-18 |
| Date Mfgr Received | 2014-05-13 |
| Device Manufacturer Date | 2013-06-01 |
| Date Added to Maude | 2014-06-10 |
| 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 | 3 |
| 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, 16F |
| Product Code | NWR |
| Date Received | 2014-05-23 |
| Catalog Number | DYNDP160116 |
| Lot Number | QXIQ |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2014-05-23 |