MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,other report with the FDA on 2020-03-18 for BARDEX? LUBRICATH? TEMPERATURE-SENSING URINE METER FOLEY TRAY 909116M manufactured by C.r. Bard, Inc. (covington) -1018233.
[183970560]
The reported event was inconclusive, as the device was not returned for evaluation. However, the potential root cause for this failure mode could be a kink inlet tube/no air vent/design issue. The lot number is unknown; therefore, the device history record could not be reviewed. The instructions for use were found adequate and state the following: "[directions for use]: 1. Method of use:the device is intended for single use only and is not reusable. 2. Precautions for use 21) since movement of the body, etc. May twist or bend catheter to cause occlusion, care should be taken to fix the catheter securely. 22) when urinary flow cannot be noted, confirm that the catheter is neither occluded nor broken. 23) avoid force on the connecting parts as they may be accidentally disconnected due to the weight of the drainage bag etc. And may cause urine spill. 24) do not pull or twist the outlet tube. Also, do not squeeze the drainage bag. [the joint of the drainage bag and the outlet tube may be damaged and urine leakage may occur. ] 25) when disposing of urine, observe the following: 1) remove the outlet tube from the housing of the urine drainage bag. 2) lift the green lever to open while holding the outlet tube. Be careful not to pull the outlet tube when lifting the green lever. 3) when disposal of urine is completed, close the green lever and put the outlet tube into the housing. [precautions]: 1. Precautions for use (exercise caution when using the device in the following patients) 1) exercise caution when using the device in patients with high urinary calcium levels as encrustation on the balloon surface, catheter occlusion or damage may occur. "
Patient Sequence No: 1, Text Type: N, H10
[183970561]
It was reported that there was a very restricted urine flow observed from the inlet tube into the drain bag.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018233-2020-01893 |
| MDR Report Key | 9849930 |
| Report Source | DISTRIBUTOR,OTHER |
| Date Received | 2020-03-18 |
| Date of Report | 2020-03-18 |
| Date of Event | 2020-02-20 |
| Date Mfgr Received | 2020-02-25 |
| Date Added to Maude | 2020-03-18 |
| 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 | BARDEX? LUBRICATH? TEMPERATURE-SENSING URINE METER FOLEY TRAY |
| Generic Name | URINE DRAINAGE BAG (CONOD) |
| Product Code | EZC |
| Date Received | 2020-03-18 |
| Catalog Number | 909116M |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2020-03-18 |