MAUDE Adverse Event Report: C.R. BARD INC. (COVINGTON) -1018233 BARD® LATEX-FREE DISPOZ-A-BAG® 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	06/16/2024
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.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 urine was not draining adequately.It was getting stuck the material was sticking together which did not allow the urine to drain causing some urine to back up into the catheter drainage tubing.
Additional Manufacturer Narrative
The reported event was inconclusive.The conditions of the sample did not allow further evaluation.Visual evaluation of the returned two-photo sample noted one opened (with original packaging), used flip flow leg bag.Visual inspection of the first photo sample noted shows the overview of the product packaging with product information.The second photo shows the flip flow leg bag with urine inside.The reported failure could not be evaluated due to the condition of the photo sample therefore this investigation is considered inconclusive.Root cause could not be identified.Although a root cause could not be definitively identified, based on the risk documentation review, a potential root cause for this type of failure could be tube length / step connector out of specification.Dhr review did not show any problems or conditions.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.Inlet flutter valve 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: d, 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 urine was not draining adequately.It was getting stuck the material was sticking together which did not allow the urine to drain causing some urine to back up into the catheter drainage tubing.

• Brand Name: BARD® LATEX-FREE DISPOZ-A-BAG® 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: 19933701
• Report Number: 1018233-2024-04735
• Device Sequence Number: 19523126
• Product Code: FAQ
• UDI-Device Identifier: 00801741050886
• UDI-Public: (01)00801741050886(11)240412(17)290131(10)NGJP0896
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2024

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: Health Professional
• Device Catalogue Number: 150832
• Device Lot Number: NGJP0896
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2024
• Supplement Date Received by Manufacturer: 10/30/2024
• Initial Report FDA Received Date: 08/07/2024
• Supplement Report FDA Received Date: 11/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/12/2024
• 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