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

Model Number	150106
Medical Device Problem Code	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/09/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient was having issues with leg bag tubing twisting and getting kink in tubing.
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 due to "defective components received from supplier." the lot number was unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: "1.Separate notches with circles.Put 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* 4.To empty dispoz-a-bag leg bag, remove cap at bottom.Important: hold green connector firmly while removing cap.5.After use, this product may be a potential biohazard.Handle and dispose of in accordance with accepted medical practise and applicable local, state and federal laws and regulations." the device was not returned.
Event or Problem Description
It was reported that the patient was having issues with leg bag tubing twisting and getting kink in tubing.

• Brand Name: BARDIA 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: 15106835
• Report Number: 1018233-2022-05782
• Device Sequence Number: 17502307
• Product Code: KNX
• UDI-Device Identifier: 00801741050749
• UDI-Public: (01)00801741050749
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 08/10/2022

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: 150106
• Device Catalogue Number: 150106
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/09/2022
• Supplement Date Received by Manufacturer: 08/10/2022
• Initial Report FDA Received Date: 07/26/2022
• Supplement Report FDA Received Date: 08/22/2022
• 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