MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other,user facility report with the FDA on 2020-03-17 for BARDEX? LUBRI-SIL? ALL-SILICONE FOLEY CATHETER 175816 manufactured by C.r. Bard, Inc. (covington) -1018233.
[187554380]
The investigation is still in progress. Once the investigation is complete, a supplemental report will be filed. The device was not returned.
Patient Sequence No: 1, Text Type: N, H10
[187554381]
It was reported that while inserting the foley catheter the water syringe came from off of the balloon. Sterile water was drawn up into a new syringe and was inserted into the balloon port. Water was very difficult to inject into the port, even with manipulation of the catheter. After a few milliliters of water was inserted and unsuccessfully the doctor requested for the bladder to finish being drained, and for the foley to be removed. The balloon port would not allow for water to be removed from the catheter balloon. A manual examination revealed that the balloon was still inflated in the bladder. The catheter had to be cut to drain the fluid from the balloon, but the balloon still would not drain. The doctor tried to drain the balloon first by using an angiocath in the balloon catheter lumen. After several attempts the doctor had to use a hypodermic needle to pop the balloon through the suburethral vaginal area. The balloon deflated and the foley catheter was removed without obvious injury to the patient and no missing pieces.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018233-2020-01836 |
| MDR Report Key | 9841471 |
| Report Source | OTHER,USER FACILITY |
| Date Received | 2020-03-17 |
| Date of Report | 2020-03-17 |
| Date of Event | 2020-02-24 |
| Date Mfgr Received | 2020-02-24 |
| Date Added to Maude | 2020-03-17 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | YONIC ANDERSON |
| Manufacturer Street | 8195 INDUSTRIAL BLVD |
| Manufacturer City | COVINGTON GA 30014 |
| Manufacturer Country | US |
| Manufacturer Postal | 30014 |
| Manufacturer Phone | 7707846100 |
| Manufacturer G1 | C.R. BARD, INC. (COVINGTON) -1018233 |
| Manufacturer Street | 8195 INDUSTRIAL BLVD |
| Manufacturer City | COVINGTON GA 30014 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 30014 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BARDEX? LUBRI-SIL? ALL-SILICONE FOLEY CATHETER |
| Generic Name | LUBRISIL CATHETER |
| Product Code | EZL |
| Date Received | 2020-03-17 |
| Model Number | 175816 |
| Catalog Number | 175816 |
| Lot Number | NGDX2505 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | C.R. BARD, INC. (COVINGTON) -1018233 |
| Manufacturer Address | 8195 INDUSTRIAL BLVD COVINGTON GA 30014 US 30014 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-17 |