MAUDE Adverse Event Report: C. R. BARD, INC. LUBRI-SIL IC COMPLETE CARE DRAINAGE BAG FOLEY / LINE DRAINAGE BAG; CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES

Model Number	303416A
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/30/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Faulty indwelling urinary catheter collection bag device not draining appropriately.Patient, with active indwelling urinary catheter, complained she had "urge" to urinate and was laying in wet linens.Urine collection bag appeared to be "sucking-in" on itself.Walls of collection bag were pulled away from each other and 900 ml of urine immediately drained into bag.Rn who reported noted this issue has happened twice in (b)(6) 2020.Bard foley catheter lot # nger4082.Fda safety report id# (b)(4).

• Brand Name: LUBRI-SIL IC COMPLETE CARE DRAINAGE BAG FOLEY / LINE DRAINAGE BAG
• Common Device Name: CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES
• Manufacturer (Section D): C. R. BARD, INC.
• MDR Report Key: 10816153
• Report Number: MW5097740
• Device Sequence Number: 11661448
• Product Code: MJC
• UDI-Device Identifier: 00801741024726
• UDI-Public: (01)00801741024726(17)230131(10)
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 11/05/2020
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Expiration Date: 01/31/2023
• Device Model Number: 303416A
• Device Catalogue Number: 303416A
• Device Lot Number: NGER4082
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/09/2020
• Patient Sequence Number: 1
• Patient Age: 88 YR
• Patient Weight: 58