MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other,study report with the FDA on 2020-02-13 for BARD? POLYURETHANE URETERAL CATHETERS, OPEN TIP 134005 manufactured by C.r. Bard, Inc. (covington) -1018233.
[179478529]
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
[179478530]
It was reported that patients often experienced pain and discomfort during use of the ureteral catheter. Information from survey: when asked about the unexpected challenges faced while using the polyurethane ureteral catheter, the respondent said "patients do tend to complain of pain and discomfort, especially asian populations of patients don? T tolerate it well". Per additional information from the survey participant with the bd clinical data collection ae survey via email 29jan2020; the ureteral catheter had to be removed due to unbearable pain, much worse than the stone itself. The patient had the stent in the first place for this reason, following ureteroscopy. The patient did not have any allergies, and the only medical intervention was to remove the bard ureteral catheter and replace it with a cook 4. 5 multi-length 26 cm ptfe ureteral catheter, which the patient was able to tolerate very well.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018233-2020-01035 |
| MDR Report Key | 9708028 |
| Report Source | OTHER,STUDY |
| Date Received | 2020-02-13 |
| Date of Report | 2020-03-03 |
| Date Mfgr Received | 2020-02-26 |
| Date Added to Maude | 2020-02-13 |
| 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 |
| 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 | BARD? POLYURETHANE URETERAL CATHETERS, OPEN TIP |
| Generic Name | URETERAL CATHETER, OPEN TIP, W/O SIDE EYE GUIDEWIRE COMPATABLE |
| Product Code | EYB |
| Date Received | 2020-02-13 |
| Catalog Number | 134005 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| 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. Other | 2020-02-13 |