MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,other report with the FDA on 2018-07-31 for BARD? POLYURETHANE URETERAL CATHETERS, WHISTLE TIP 136406 manufactured by C.r. Bard, Inc. (covington) -1018233.
[115795148]
Per direction by fda in a letter dated, july 20, 2018, this emdr is being filed to submit new information obtained based on the complaint investigation results. The initial report for this event was submitted in the quarter 1 2018 asr report. However, supplemental reports regarding the asr are no longer being accepted. It was agreed upon with the fda that the date of awareness would be the date of the letter received, which is july 20, 2018. Received 1 catheter for evaluation. The reported event was unconfirmed as the product meet specifications. The exterior of the sample was visually inspected and did not find any evidence of a failure that would support the reported event. Per the functional evaluation, the sample was compared to our visual standard and it matched. The device history record was reviewed and found nothing that could have caused or contributed to the reported event. The instructions for use state the following: contraindications 2. Precautions for use (1) do not withdraw ureteral catheter while it is deflected in endoscope. It is possible that the catheter may dissect or fracture. (2) avoid sharp bending. (3) do not over-tighten the catheter adapter. Over-tightening the catheter adapter may occlude the lumen of the catheter. The information provided by bard 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 bard.
Patient Sequence No: 1, Text Type: N, H10
[115795149]
It was reported that the hole of the distal tip of the catheter had collapsed as the package was opened. The catheter was not used. Reason for report: investigation results. (b)(4). Initial asr report submitted: quarter 1/2018. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018233-2018-03151 |
| MDR Report Key | 7737312 |
| Report Source | DISTRIBUTOR,OTHER |
| Date Received | 2018-07-31 |
| Date of Report | 2018-07-31 |
| Date of Event | 2018-02-13 |
| Date Mfgr Received | 2018-07-20 |
| Device Manufacturer Date | 2017-05-18 |
| Date Added to Maude | 2018-07-31 |
| 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 | BARD? POLYURETHANE URETERAL CATHETERS, WHISTLE TIP |
| Generic Name | URETERAL CATHETER |
| Product Code | EYB |
| Date Received | 2018-07-31 |
| Returned To Mfg | 2018-03-02 |
| Catalog Number | 136406 |
| Lot Number | MYBST521 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| 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 | 2018-07-31 |