MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,other report with the FDA on 2020-03-18 for BARDEX? FOLEY CATHETER SILICONE COATED 0167V18S manufactured by C.r. Bard, Inc. (covington) -1018233.
[184451089]
The investigation is still in progress. Once the investigation is complete, a supplemental report will be filed. The information provided by bd represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
Patient Sequence No: 1, Text Type: N, H10
[184451090]
It was reported that the catheter balloon was difficult to deflate, and would not deflate in the passive ifu instructed way. The user used the syringe to try and forcibly pull out the water but only 2 ml would come out. Next the physician cut the inflation lumen to drain the catheter but once again no water would come out. Last a guidewire was used thru the inflation lumen and cleared the occlusion and the water was removed. The catheter was visually inspected once removed and there was no damage to the catheter balloon.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018233-2020-01885 |
| MDR Report Key | 9848582 |
| Report Source | COMPANY REPRESENTATIVE,OTHER |
| Date Received | 2020-03-18 |
| Date of Report | 2020-04-02 |
| Date of Event | 2020-02-22 |
| Date Mfgr Received | 2020-03-29 |
| Date Added to Maude | 2020-03-18 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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? FOLEY CATHETER SILICONE COATED |
| Generic Name | BARDIA 3 WAY CATHETER |
| Product Code | KOD |
| Date Received | 2020-03-18 |
| Catalog Number | 0167V18S |
| Lot Number | UNK |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| 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 | 2020-03-18 |