MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,other report with the FDA on 2020-03-13 for BARDIA? COUDE OLIVE TIP URETHRAL FOLEY CATHETER 802514 manufactured by C.r. Bard, Inc. (covington) -1018233.
[186178736]
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
[186178737]
It was reported that the diameter around the catheter bunched up. The patient stated he received both straight and curved catheters from supplier. He noticed a difference in the diameter/shape of the catheter, and the patient did not use the catheters. Per follow-up the customer on (b)(6) 2020, it was clarified that the diameter seemed thicker because the catheter bunched up at the tip. The difference in the shape was clarified by the end user. It was stated that the coude catheter was not curved enough and some of the tips appeared to be straight. The catheters have not been used, and the patient was using our male externals.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018233-2020-01815 |
| MDR Report Key | 9832403 |
| Report Source | CONSUMER,OTHER |
| Date Received | 2020-03-13 |
| Date of Report | 2020-03-13 |
| Date Mfgr Received | 2020-02-18 |
| Date Added to Maude | 2020-03-13 |
| 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 | BARDIA? COUDE OLIVE TIP URETHRAL FOLEY CATHETER |
| Generic Name | COUDE INTERMITTENT CATHETER |
| Product Code | KOD |
| Date Received | 2020-03-13 |
| Model Number | 802514 |
| Catalog Number | 802514 |
| Lot Number | NGDW0973 |
| Operator | LAY USER/PATIENT |
| 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 | 2020-03-13 |