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

Model Number	150719
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2022
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.The device was not returned.
Event or Problem Description
It was reported that the urinary drain bag was leaking, and this was the second time it has happened, and it leaked near the tube outlet hub.Per follow-up via phone on (b)(6) 2022, it was reported that the two bags were leaking around the edges of the circle at the base of the drain tube.Also reported that, the patient experienced bleeding and seeping skin from using the male external catheters, and they used cleaning prep in the past but that did not help with the problem.Patient consulted physicians and asked questions, but no solution was provided.No medical intervention reported.Also reported that, the patient was cleaning and reusing the urinary drain bags and questioned regarding cleaning the product and stated the tubes were dirty.
Event or Problem Description
It was reported that the urinary drain bag was leaking, and this was the second time it has happened, and it leaked near the tube outlet hub.Per follow-up via phone on 09feb2022, it was reported that the two bags were leaking around the edges of the circle at the base of the drain tube.Also reported that, the patient experienced bleeding and seeping skin from using the male external catheters, and they used cleaning prep in the past but that did not help with the problem.Patient consulted physicians and asked questions, but no solution was provided.No medical intervention reported.Also reported that, the patient was cleaning and reusing the urinary drain bags and questioned regarding cleaning the product and stated the tubes were dirty.
Additional Manufacturer Narrative
The reported event was inconclusive because no sample was returned for evaluation.A potential root cause for this failure could be due to "defective components from the supplier".It was unknown whether the device had met specifications.The product is intended to be used for treatment purpose but it is unknown if there is a relationship between the reported event and the device.The device was not returned for evaluation.The lot number is unknown; therefore, the device history record could not be reviewed.A labeling review was not performed because labeling could not have prevented the reported failure.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
• 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: juan velez ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 13685779
• Report Number: 1018233-2022-01082
• Device Sequence Number: 4930165
• Product Code: FAQ
• UDI-Device Identifier: 00801741050855
• UDI-Public: (01)00801741050855
• Combination Product (Y/N): N
• Initial Reporter State: DE
• 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): 06/23/2022

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: 150719
• Device Catalogue Number: 150719
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/09/2022
• Supplement Date Received by Manufacturer: 06/23/2022
• Initial Report FDA Received Date: 03/08/2022
• Supplement Report FDA Received Date: 07/13/2022
• 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