MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD URINARY DRAINAGE BAG; DRAIN BAG

Model Number	603402
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.
Event or Problem Description
It was reported that the drainage bags was not draining.
Event or Problem Description
It was reported that the drainage bags was not draining.As per the follow up information received via email on 08sep2020,the customer noted that the clip on the bottom of the bag was not stay closed which caused the urine to continuously drain out of the bag and confirmed no issue with the urine draining into the bag.And also reported, the drainage bag was used with the male external catheter.
Additional Manufacturer Narrative
Upon further review, bd has determined that this mdr was initially reported in error as this event is not reportable.

• Brand Name: BARD URINARY DRAINAGE BAG
• Common Device Name: DRAIN BAG
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 10497344
• Report Number: 1018233-2020-05731
• Device Sequence Number: 3860200
• Product Code: KNX
• UDI-Device Identifier: 00801741029523
• UDI-Public: (01)00801741029523
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,distributor,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 603402
• Device Catalogue Number: 603402
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/13/2020
• Supplement Date Received by Manufacturer: 12/07/2020
• Initial Report FDA Received Date: 09/04/2020
• Supplement Report FDA Received Date: 12/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1