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	08/20/2024
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 bag did not drain.
Event or Problem Description
It was reported that the leg bag did not drain.
Additional Manufacturer Narrative
The reported event was inconclusive because no sample was available for evaluation and further investigation did not result in any additional findings.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 ¿vent blocked creating vacuum in bag (excludes non vented bags), occlusions (for bed or leg bags)".However, there was insufficient information to confirm this potential root cause.A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.The instructions for use were found adequate and state the following: "bard deluxe fabric leg straps directions for use: 1.Insert soft loop pad end of strap through strap slits on leg bag, so that straps run behind bag, and loop pad faces bag.2.Wrap straps around leg, either on thigh or calf.(if straps are too long, remove leg bag.Cut straps at separations between loop pads, only, to achieve desired length.) 3.Locate leg bag on inside of leg and connect strap ends by pressing together.Straps must fit snugly but must be comfortable.Washing instructions: do not use bleach.Wash in warm water." 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 bag did not drain.
Additional Manufacturer Narrative
The reported event was inconclusive because no sample was available for evaluation and further investigation did not result in any additional findings.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 ¿vent blocked creating vacuum in bag (excludes non vented bags), occlusions (for bed or leg bags)".However, there was insufficient information to confirm this potential root cause.A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.The instructions for use were found adequate and state the following: "bard deluxe fabric leg straps directions for use: 1.Insert soft loop pad end of strap through strap slits on leg bag, so that straps run behind bag, and loop pad faces bag.2.Wrap straps around leg, either on thigh or calf.(if straps are too long, remove leg bag.Cut straps at separations between loop pads, only, to achieve desired length.) 3.Locate leg bag on inside of leg and connect strap ends by pressing together.Straps must fit snugly but must be comfortable.Washing instructions: do not use bleach.Wash in warm water." 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.

• 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 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: 20168826
• Report Number: 1018233-2024-05644
• Device Sequence Number: 12540794
• Product Code: FAQ
• UDI-Device Identifier: 00801741050886
• UDI-Public: (01)00801741050886(11)240519(17)290228(10)NGJQ0343
• 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,Followup
• Report Date (Section B): 11/05/2024

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: NGJQ0343
• 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: 08/21/2024
• Supplement Date Received by Manufacturer: 09/20/2024; 11/06/2024
• Initial Report FDA Received Date: 09/09/2024
• Supplement Report FDA Received Date: 09/23/2024; 11/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/19/2024
• 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: Male