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	Biocompatibility (2886)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	12/11/2020
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.
Event or Problem Description
It was reported that the patient had experienced bladder infection as everything drained down to tube.Patient believed that being tilted back in the wheelchair might have been part of the problem.It was unknown what medical intervention was provided for bladder infection.
Additional Manufacturer Narrative
The reported event was inconclusive as no sample returned for evaluation.It was unknown whether the device had met relevant specifications.The product used for the treatment purposes.It was unknown whether the product had caused the reported failure.A potential root cause for this failure mode could be due to the materials of construction were not biocompatible.The device was not returned for evaluation.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: "directions for use: 1.Separate notches within 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." correction: e, h.H11:section a through f - the information provided by bd 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 bd.
Event or Problem Description
It was reported that the patient had experienced bladder infection as everything drained down to the tube.The patient believed that being tilted back in the wheelchair might have been part of the problem.It is unknown what medical intervention was provided for the bladder infection.

• 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
• MDR Report Key: 11120888
• Report Number: 1018233-2020-22282
• Device Sequence Number: 19846247
• Product Code: KNX
• UDI-Device Identifier: 00801741050725
• UDI-Public: (01)00801741050725
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2021

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: 150102
• Device Catalogue Number: 150102
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/11/2020
• Supplement Date Received by Manufacturer: 03/26/2021
• Initial Report FDA Received Date: 01/05/2021
• Supplement Report FDA Received Date: 04/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other