MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,distributor,other report with the FDA on 2020-01-17 for BARD? TOUCHLESS? PLUS UNISEX PRE-LUBRICATED VINYL URETHRAL CATHETER KIT 4A5144 manufactured by C.r. Bard, Inc. (covington) -1018233.
[175433682]
The reported event could not be confirmed, and it was unknown whether the device had met specifications due to no sample being returned for evaluation. The product was used for treatment purposes, and a potential failure mode could be? Missing components /accessories? With a potential root cause of? Incorrect operation?. The device history record was reviewed and found nothing that could have caused or contributed to the reported event. The instructions for use were found adequate and state the following: "open kit and remove contents. The gloves are not necessary to maintain aseptic conditions during the procedure. The gloves are for the operator's protection. "
Patient Sequence No: 1, Text Type: N, H10
[175433683]
It was reported that 6 of the catheter kits did not have catheters inside.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018233-2020-00403 |
| MDR Report Key | 9602444 |
| Report Source | CONSUMER,DISTRIBUTOR,OTHER |
| Date Received | 2020-01-17 |
| Date of Report | 2020-01-17 |
| Date Mfgr Received | 2019-12-26 |
| Device Manufacturer Date | 2019-06-28 |
| Date Added to Maude | 2020-01-17 |
| 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? TOUCHLESS? PLUS UNISEX PRE-LUBRICATED VINYL URETHRAL CATHETER KIT |
| Generic Name | TOUCHLESS PLUS |
| Product Code | FCM |
| Date Received | 2020-01-17 |
| Model Number | 4A5144 |
| Catalog Number | 4A5144 |
| Lot Number | NGDS3506 |
| 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 | 2020-01-17 |