MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDEX® LUBRICATH® FOLEY CATHETER TRAY; LUBRICATH DRAIN BAG

Model Number	899914
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Urinary Tract Infection (2120)
Date of Event	09/24/2018
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 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.
Event or Problem Description
It was reported that during urine drainage, a fracture was observed at the tubing junction seal and at the base of the collection bag.The patient had a urinary tract infection after this event.Per additional information received on 10-oct-2018, the patient received treatment for the urinary tract infection.The type of medication is unknown.
Event or Problem Description
It was reported that during urine drainage, a fracture was observed at the tubing junction seal and at the base of the collection bag.The patient had a urinary tract infection after this event.Per additional information received on (b)(6)2018 , the patient received treatment for the urinary tract infection.The type of medication is unknown.
Additional Manufacturer Narrative
The reported event was confirmed.Visual evaluation of the sample noted that the inlet tubing was broken upon return.The inlet tubing was torn all the way through, and only the portion of the inlet tubing that connected to the dome was returned.A potential failure mode could be cracked tubing.A potential root cause for this failure mode could be brittle material- inappropriate material choice.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: ¿1.Wash hands and don clean gloves 2.Using proper aseptic technique open outer csr wrap 3.Place underpad beneath patient, plastic/¿shiny¿ side down 4.Use the provided cleansing wipe to cleanse patient¿s peri-urethral area 5.Remove gloves and perform hand hygiene with provided alcohol hand sanitizer gel.".

• Brand Name: BARDEX® LUBRICATH® FOLEY CATHETER TRAY
• Common Device Name: LUBRICATH DRAIN BAG
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 7987041
• Report Number: 1018233-2018-04861
• Device Sequence Number: 1572166
• Product Code: EZC
• UDI-Device Identifier: 00801741024801
• UDI-Public: (01)00801741024801
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K910846
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/28/2018

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: Health Professional
• Device Expiration Date: 09/30/2020
• Device Model Number: 899914
• Device Catalogue Number: 899914
• Device Lot Number: NGBZ3900
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2018
• Initial Date Received by Manufacturer: 09/26/2018
• Supplement Date Received by Manufacturer: 12/07/2018
• Initial Report FDA Received Date: 10/19/2018
• Supplement Report FDA Received Date: 12/28/2018
• 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: Required Intervention