MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDIA® CLOSED SYSTEM URINARY DRAINAGE BAG WITH ANTI-REFLUX CHAMBER; DRAIN BAG

Model Number	802001
Medical Device Problem Code	Restricted Flow rate (1248)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the customer had same drain bag they have called about.Stated that they use it at night only, during the night patient had to get up multiple times to empty it because they feel pressure from the tubing or bag like it was not draining.Representative reviewed possible vapor lock on new bag and explained how to separate material to break vapor lock which might cause urine to back up into tubing.Also explained how system could vapor lock if the air vent gets wet.Patient denies getting vent wet.Per follow-up via phone on 19may2023, it was reported that the customer's current supplier was vitality medical and the customer was dealing with incontinence and slept on their left side with the drain bag attached to their bed rail roughly below their hip.The pressure they had been feeling was mainly in the penis, and the drain bag was only levelling out to 300 cc.They ran water through the drain bag at times to see if the issue would resolve itself, and sometimes it did not.The results were the same regardless.They noticed the pressure buildup every 2 hours after reapplying their texas catheter to the drain bag, and they just had an artificial sphincter activated 2 days ago.They also wear disposable underwear in the event of any accidents.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.H11: section a through f - the information provided by bd represents all 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 bd.H3 other text : the device was not returned.
Event or Problem Description
It was reported that the customer had same drain bag they have called about.Stated that they use it at night only, during the night patient had to get up multiple times to empty it because they feel pressure from the tubing or bag like it was not draining.Representative reviewed possible vapor lock on new bag and explained how to separate material to break vapor lock which might cause urine to back up into tubing.Also explained how system could vapor lock if the air vent gets wet.Patient denies getting vent wet.Per follow-up via phone on 19may2023, it was reported that the customer's current supplier was vitality medical and the customer was dealing with incontinence and slept on their left side with the drain bag attached to their bed rail roughly below their hip.The pressure they had been feeling was mainly in the penis, and the drain bag was only levelling out to 300 cc.They ran water through the drain bag at times to see if the issue would resolve itself, and sometimes it did not.The results were the same regardless.They noticed the pressure buildup every 2 hours after reapplying their texas catheter to the drain bag, and they just had an artificial sphincter activated 2 days ago.They also wear disposable underwear in the event of any accidents.
Additional Manufacturer Narrative
Upon further review, bd has determined that this mdr was reported in error as it was found to be a duplicate of an event previously reported.H11: section a through f - the information provided by bd represents all 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 bd.H3 other text: the device was not returned.

• Brand Name: BARDIA® CLOSED SYSTEM URINARY DRAINAGE BAG WITH ANTI-REFLUX CHAMBER
• Common Device Name: DRAIN BAG
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 17058244
• Report Number: 1018233-2023-04013
• Device Sequence Number: 15160678
• Product Code: KNX
• UDI-Device Identifier: 00801741040740
• UDI-Public: (01)00801741040740
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2023

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: 802001
• Device Catalogue Number: 802001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2023
• Supplement Date Received by Manufacturer: 06/08/2023
• Initial Report FDA Received Date: 06/05/2023
• Supplement Report FDA Received Date: 06/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown