MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-04-25 for HYDROPHILLIC-COATED FOLEY CATHETER 5 CC BALLOON 899716 manufactured by C.r. Bard.
[17409584]
Foley catheter was inserted at around 10:05 am without difficulty. Balloon was slightly inflated and deflated with sterile water. Balloon was intact. Clear amber urine was noted, balloon was inflated with 10 ml of sterile water. Gemzar (chemo drug) was instilled without difficulty, tubing was clamped per procedure. Around 10:40 am, there was some slight leaking around the catheter. Unclamped the tubing and released some urine into the foley bag. Reclamped per procedure and leaking has now stopped. Around 10:45 am, the pt states he felt like the balloon burst and heard a loud pop. Foley was immediately removed and in fact the balloon had burst. The pt immediately urinated into the urinal without difficulty. It was noted there was small object (possible balloon) at the bottom of urinal. Around 10:47, physician at bedside and order, begin to administer fluids. Pt was instructed to contact urologist. Unfortunately the urologist was out of town and was advised to go to the ed for further monitoring and eval.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5025199 |
| MDR Report Key | 2554567 |
| Date Received | 2012-04-25 |
| Date of Report | 2012-04-25 |
| Date of Event | 2012-03-30 |
| Date Added to Maude | 2012-05-02 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HYDROPHILLIC-COATED FOLEY CATHETER 5 CC BALLOON |
| Product Code | NWR |
| Date Received | 2012-04-25 |
| Catalog Number | 899716 |
| Lot Number | NGWA1089 |
| Device Expiration Date | 2014-10-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | C.R. BARD |
| Manufacturer Address | COVINGTON GA 30014 US 30014 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2012-04-25 |