MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 SURESTEP¿ FOLEY TRAY SYSTEM BARD® LUBRICATH® FOLEY CATHETER TRAY; DRAIN BAG

Catalog Number A800064

Device Problems No Device Output (1435); Material Integrity Problem (2978)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.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.

Event Description

It was reported that the drain bag seems to be missing the drainage hole, and is not draining from the green connection port.

Manufacturer Narrative

The reported issue (the drain bag seems to be missing the drainage hold and is not draining where the green connection port is) was confirmed as a manufacturing related issue.Visual inspection noted the urine appeared to not drain from the outlet port.During the evaluation of the sample, it was noticed that the urine residues were remaining in the lower part of the bag, it seemed that the urine would not go through the outlet tube.It was noted that the perforation in the outlet tube was missing.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: ¿visually inspect the product for any imperfections or surface deterioration prior to use.If package is opened or if any imperfection or surface deterioration is observed, do not use.".

Event Description

It was reported that the drain bag seemed to be missing the drainage hole, and was not draining from the green connection port.

• Brand Name: SURESTEP¿ FOLEY TRAY SYSTEM BARD® LUBRICATH® FOLEY CATHETER TRAY
• Type of Device: DRAIN BAG
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer Contact: amy gravley ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 6753986
• MDR Text Key: 81538932
• Report Number: 1018233-2017-04043
• Device Sequence Number: 1
• Product Code: EZC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K910846
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: A800064
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/26/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1