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 2020-02-25 for BARD? TOUCHLESS? PLUS UNISEX PRE-LUBRICATED VINYL URETHRAL CATHETER KIT 4A5142 manufactured by C.r. Bard, Inc. (covington) -1018233.
[188335165]
The investigation is still in progress. Once the investigation is complete, a supplemental report will be filed.
Patient Sequence No: 1, Text Type: N, H10
[188335166]
It was reported that the catheter portion of the touchless plus intermittent catheter system was found inside the patient's bladder. Due to frequent uti's the patient received an ultrasound. The catheter was found coiled inside the bladder and anchored by encrustation. After the catheter was removed it was compared to the touchless plus intermittent kit to determine what the product was inside the body. The catheter that was removed came out discolored a yellowish hue. It was reported that the patient had been having regular intermittent catheters inserted to empty his bladder at least 4 times a day.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018233-2020-01327 |
| MDR Report Key | 9751913 |
| Report Source | COMPANY REPRESENTATIVE,OTHER, |
| Date Received | 2020-02-25 |
| Date of Report | 2020-02-25 |
| Date Mfgr Received | 2020-02-04 |
| Date Added to Maude | 2020-02-25 |
| 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? TOUCHLESS? PLUS UNISEX PRE-LUBRICATED VINYL URETHRAL CATHETER KIT |
| Generic Name | TOUCHLESS PLUS INTERMITTENT CATHETER SYSTEM |
| Product Code | FCM |
| Date Received | 2020-02-25 |
| Catalog Number | 4A5142 |
| Lot Number | NGCZ3612 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| 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 | 2020-02-25 |