MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 LEG BAG WITH FLIP-FLO DRAINAGE VALVE

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	07/05/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the customer did not understand the anti-reflux valve was not letting some of the liquid go down.Customer stated that they looked at another clean, unused bag and saw the valve inside that needed a large amount of pressure to open.Also said they usually used a tissue to help collect any liquid to prevent it from spilling.Representative advised it was a possible vapor lock and stated that there was a flutter valve on the inside that opened up to let urine through and then closed to prevent back flow into the bladder.Residual liquid left over may not be enough pressure to push flutter valve open which could lead to it sitting at the top of the tubing that connected to the catheter, suggested needing between fingers to assist in releasing liquid into bag or using tissue to catch residual during change.
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 customer did not understand the anti-reflux valve was not letting some of the liquid go down.Customer stated that they looked at another clean, unused bag and saw the valve inside that needed a large amount of pressure to open.Also said they usually used a tissue to help collect any liquid to prevent it from spilling.Representative advised it was a possible vapor lock and stated that there was a flutter valve on the inside that opened up to let urine through and then closed to prevent back flow into the bladder.Residual liquid left over may not be enough pressure to push flutter valve open which could lead to it sitting at the top of the tubing that connected to the catheter, suggested needing between fingers to assist in releasing liquid into bag or using tissue to catch residual during change.
Additional Manufacturer Narrative
The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be due to "obstruction in tube / kinked tubing".It is unknown whether the device had met relevant specifications.The product was used for treatment purposes.It was unknown whether the product had caused the reported failure.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: "bard® dispoz-a-bag® leg bag with flip-flo¿ drainage valve a vinyl leg bag to be used with male external catheters, foley catheters or most other types of urinary catheters.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.(b)(4) or (b)(4)).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.Bard® dispoz-a-bag® accessories: ¿ leg bag holder ¿ 1-3/4¿ wide leg bag strap ¿ deluxe fabric leg bag straps ¿ extension tubing" correction: d.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: LEG BAG WITH FLIP-FLO DRAINAGE VALVE
• Common Device Name: LEG 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: 17396039
• Report Number: 1018233-2023-05488
• Device Sequence Number: 5680115
• Product Code: FAQ
• UDI-Device Identifier: 00801741050886
• UDI-Public: (01)00801741050886
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 08/28/2023
• 2 Devices were Involved in the Event: 1 2

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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/05/2023
• Supplement Date Received by Manufacturer: 08/28/2023
• Initial Report FDA Received Date: 07/26/2023
• Supplement Report FDA Received Date: 08/29/2023
• 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