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

Device Problem Fluid/Blood Leak (1250)

Patient Problem Fall (1848)

Event Date 02/22/2023

Event Type  Injury  

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 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.

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 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
• Type of Device: 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
• MDR Text Key: 311371056
• Report Number: 1018233-2023-01765
• Device Sequence Number: 1
• Product Code: KNX
• UDI-Device Identifier: 00801741050725
• UDI-Public: (01)00801741050725
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• 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
• Date Manufacturer Received: 04/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/04/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization