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

Model Number	150732
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Urinary Tract Infection (2120)
Date of Event	09/29/2022
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
It was reported that the patient had two urinary tract infections in two different occasions.Patient went to the doctors and they told it was because the patient did not have enough leg bags.Patient wanted twelve leg bags every ninety days.Patient said they would be asking their doctor to send in new prescription.Per follow up via phone on (b)(6) 2022, it was reported that the patient went to the hospital about urinary tract infection.Stated that patient was on intravenous antibiotics (iv) and oral antibiotics.It was advised by doctor to change their leg bags more frequently, therefore the doctor prescribed more bags for the patient.
Additional Manufacturer Narrative
The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be "materials of construction are not biocompatible".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).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: g 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.
Event or Problem Description
It was reported that the patient had two urinary tract infections in two different occasions.The patient went to the doctors, and they told it was because the patient did not have enough leg bags.Patient wanted twelve leg bags every ninety days.The patient said they would be asking their doctor to send in a new prescription.Per follow up via phone on 07oct2022, it was reported that the patient went to the hospital about urinary tract infection.Stated that patient was on intravenous antibiotics (iv) and oral antibiotics.It was advised by doctor to change their leg bags more frequently, therefore the doctor prescribed more bags for the patient.

• Brand Name: 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 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 15579636
• Report Number: 1018233-2022-07745
• Device Sequence Number: 6498894
• Product Code: FAQ
• UDI-Device Identifier: 00801741050862
• UDI-Public: (01)00801741050862
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 02/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 150732
• Device Catalogue Number: 150732
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/29/2022
• Supplement Date Received by Manufacturer: 02/01/2023
• Initial Report FDA Received Date: 10/11/2022
• Supplement Report FDA Received Date: 02/14/2023
• 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: Required Intervention
• Patient Sex: Male