MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 LEG BAG WITH RUBBER CAP VALVE (ONE PAIR OF LATEX STRAPS), 19OZ., STERILE; DISPOS-A-BAG

Model Number	150102
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Fall (1848)
Date of Event	02/22/2023
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 customer used the leg bag on their left leg, there was a faulty valve at the bottom that dripped urine on their leg.There was a screw on valve and when it was turned off it still leaked.When they went to the bathroom to clean it up, the urine dripping down their leg caused the patient to slip and fall.As a result, the patient was badly injured and was hospitalized for roughly 4-5 days.Customer still had catheter bag that could be shipped in for investigation.Per customer via phone on (b)(6) 2023, patient is still being treated for injury from the fall.Stated the drain bag had been in use for the day at the time the leak occurred.Customer states that this has happened one time.
Additional Manufacturer Narrative
The reported event was inconclusive because no sample was returned for evaluation.A potential root cause for this failure could be "brittle material ¿ inappropriate material choice".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.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: "directions for use: separate notches within circles.Put straps through holes and around leg position bag on leg with flutter valve at top.Attach catheter or extension tubing to top inlet.When wearing bag below knee, attach bard extension tubing." h11: section a through f - the information provided by bard 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 bard.H3 other text: the device was not returned.
Event or Problem Description
It was reported that the customer used the leg bag on their left leg, there was a faulty valve at the bottom that dripped urine on their leg.There was a screw on valve and when it was turned off it still leaked.When they went to the bathroom to clean it up, the urine dripping down their leg caused the patient to slip and fall.As a result, the patient was badly injured and was hospitalized for roughly 4-5 days.Customer still had catheter bag that could be shipped in for investigation.Per customer via phone (b)(6) 2023, patient is still being treated for injury from the fall.Stated the drain bag had been in use for the day at the time the leak occurred.Customer states that this has happened one time.

• Brand Name: LEG BAG WITH RUBBER CAP VALVE (ONE PAIR OF LATEX STRAPS), 19OZ., STERILE
• Common Device Name: DISPOS-A-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: 16548019
• Report Number: 1018233-2023-01765
• Device Sequence Number: 6453132
• Product Code: KNX
• UDI-Device Identifier: 00801741050725
• UDI-Public: (01)00801741050725
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 04/27/2023

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 06/30/2026
• Device Model Number: 150102
• Device Catalogue Number: 150102
• Device Lot Number: NGFT2992
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/22/2023
• Supplement Date Received by Manufacturer: 04/28/2023
• Initial Report FDA Received Date: 03/15/2023
• Supplement Report FDA Received Date: 05/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/04/2021
• 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: Hospitalization
• Patient Sex: Unknown