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

Model Number	150819
Medical Device Problem Codes	Inadequate or Insufficient Training (1643); Illegible Information (4050)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that leg bag and drain bag were leaking at all the connection points from the male external catheter to the bags.Customer asked how to connect it.Representative explained customer that the connections were friction fit devices with universal transition parts.And without a strong force to push friction fittings together, the connections would likely come loose with little effort, resulting in leaks.Also, representative advised to slightly twist connection back and forth while pushing down to help properly seat drainage connections.And the same advice would be for the beside or the leg bag connections.They could not confirm if the patient was pushing the male external catheter onto the drain bag connector as far as it would go and suspected that the parts were not connected properly, or the transition connectors not glued into place on drainage bags.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The device was not returned.
Additional Manufacturer Narrative
The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be ¿missing instructions or vendor/printer error¿.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 device was not returned for evaluation.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: "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." h11:section a through f - the information provided by bd represents all of 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 leg bag and drain bag were leaking at all the connection points from the male external catheter to the bags.Customer asked how to connect it.Representative explained customer that the connections were friction fit devices with universal transition parts.And without a strong force to push friction fittings together, the connections would likely come loose with little effort, resulting in leaks.Also, representative advised to slightly twist connection back and forth while pushing down to help properly seat drainage connections.And the same advice would be for the beside or the leg bag connections.They could not confirm if the patient was pushing the male external catheter onto the drain bag connector as far as it would go and suspected that the parts were not connected properly, or the transition connectors not glued into place on drainage bags.

• Brand Name: LEG BAG WITH FLIP FLO 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: yonic anderson ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 12923658
• Report Number: 1018233-2021-07717
• Device Sequence Number: 20225980
• Product Code: FAQ
• UDI-Device Identifier: 00801741050879
• UDI-Public: (01)00801741050879
• Combination Product (Y/N): N
• Initial Reporter State: NH
• 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,Consumer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/25/2022

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: 150819
• Device Catalogue Number: 150819
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/12/2021
• Supplement Date Received by Manufacturer: 01/25/2022
• Initial Report FDA Received Date: 12/03/2021
• Supplement Report FDA Received Date: 02/16/2022
• 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