MAUDE Adverse Event Report: C.R. BARD INC. (COVINGTON) -1018233 LEG BAG

Catalog Number	150832
Medical Device Problem Code	Restricted Flow rate (1248)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/02/2024
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.This report references a us equivalent device.The us udi equivalent for this product number is used.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.
Event or Problem Description
It was reported that the leg bags, as a result of medication, have recently become incontinent.They had been using this bard dispose-a-bag leg bag (large 32 oz) attached to shin, with a variety of external male catheters.Customers drive seniors all day and, therefore, the customer is seated in the car when emptying their bladder.They are often unable to completely empty the bag in a timely manner.When they pee, the tube from the catheter to the bag does not drain and a vacuum forms between the catheter and the bag.As a result, the urine backs up in the catheter even when they are able to stand and the urine ¿dissolves¿ the catheter glue and the catheter disconnects from the tubing.Of course, there was a resulting leak or flood.In an attempt to solve this, if they have time, they briefly loosen the connection from the catheter to the tube enough to allow air into the tube to release the vacuum.There were tried inserting a small tube into the tube just where it attaches to the main tube as seen here.It did not work, only leaked as they were using it.
Additional Manufacturer Narrative
The reported event was inconclusive.No actions can be taken at this time since a root cause was not identified.The conditions of the sample did not allow further evaluation.Visual evaluation of the returned one-photo sample noted one opened (without original packaging), used leg bag extension tubing.Visual inspection of the one-photo sample noted that a red straw like plastic stick was taped to the extension tube.The device history record review could not be performed without a lot number.The instructions for use were found adequate and state the following: directions for use: 1.Separate notches within circles.Pull straps through holes and around leg.2.Position bag on leg with flutter valve at top.3.Attach catheter or extension tubing to top inlet.When wearing bag below knee, attach bard extension tubing (catalog no.150615 or 4a4194).When using extension tubing, make sure to connect tube at least to the 3rd taper of the connector.4.To empty dispoz-a-bag, push green lever on flip-flo valve out and down.Important: be sure to reclose flip-flo valve after emptying bag.5.After use, this product may be a potential biohazard.Handle and dispose of in accordance with accepted medical practice and applicable, local, state and federal laws and regulations.Correction: h.This report references a us equivalent device.The us udi equivalent for this product number is used.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.
Event or Problem Description
It was reported that the leg bags, as a result of medication, have recently become incontinent.They had been using this bard dispose-a-bag leg bag (large 32 oz) attached to shin, with a variety of external male catheters.Customers drive seniors all day and, therefore, the customer is seated in the car when emptying their bladder.They are often unable to completely empty the bag in a timely manner.When they pee, the tube from the catheter to the bag does not drain and a vacuum forms between the catheter and the bag.As a result, the urine backs up in the catheter even when they are able to stand and the urine ¿dissolves¿ the catheter glue and the catheter disconnects from the tubing.Of course, there was a resulting leak or flood.In an attempt to solve this, if they have time, they briefly loosen the connection from the catheter to the tube enough to allow air into the tube to release the vacuum.There were tried inserting a small tube into the tube just where it attaches to the main tube as seen here.It did not work, only leaked as they were using it.

• Brand Name: LEG BAG
• Common Device Name: LEG 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: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 20759803
• Report Number: 1018233-2024-07457
• Device Sequence Number: 18240918
• Product Code: FAQ
• UDI-Device Identifier: 00801741050886
• UDI-Public: (01)00801741050886
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/18/2025

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 Catalogue Number: 150832
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/02/2024
• Supplement Date Received by Manufacturer: 02/18/2025
• Initial Report FDA Received Date: 11/22/2024
• Supplement Report FDA Received Date: 02/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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