MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDEX® MALECOT MODEL DRAIN; BARDEX MALECDOT MODEL DRAIN

Model Number 086034

Device Problems Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemorrhage/Bleeding (1888); Ulceration (2116); Ulcer (2274)

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 patient had bleeding from the tube and a sigmoidoscopy revealed a rectal ulcer and a visible vessel.The tube was placed for fecal incontinence management of liquid stools in an immunocompromised patient with ulcerative colitis.This device is for urological purposes only.The device was in place for 29 days.The bleeding was stopped via clipping of the vessel.

Manufacturer Narrative

The device was not returned for evaluation.A potential root cause of the reported event could be patient allergies to latex material due to which there was formation of ulcer in the rectum, resulting in bleeding.The lot number is unknown therefore the device history record could not be reviewed.The instructions for use were found adequate and state the following: ¿warning: do not use ointments or lubricants having a petrolatum base.They will damage latex.Visually inspect the product for any imperfections or surface deterioration prior to use.Storage: store catheters at room temperature away from direct exposure to light, preferably in the original box.This is a single use device.Do not resterilize any portion of this device.Reuse and/or repackaging may create a risk of patient or user infection, compromise the structural integrity and/or essential material and design characteristics of the device, which may lead to device failure, and/or lead to injury, illness or death of the patient." 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.H3 other text : the device was not returned.

Event Description

It was reported that the patient had bleeding from the tube and a sigmoidoscopy revealed a rectal ulcer and a visible vessel.The tube was placed for fecal incontinence management of liquid stools in an immunocompromised patient with ulcerative colitis.This device is for urological purposes only.The device was in place for 29 days.The bleeding was stopped via clipping of the vessel.

• Brand Name: BARDEX® MALECOT MODEL DRAIN
• Type of Device: BARDEX MALECDOT MODEL DRAIN
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8739158
• MDR Text Key: 149342197
• Report Number: 1018233-2019-03403
• Device Sequence Number: 1
• Product Code: FEW
• UDI-Device Identifier: 00801741023934
• UDI-Public: (01)00801741023934
• Combination Product (y/n): N
• PMA/PMN Number: K070879
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 08/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 086034
• Device Catalogue Number: 086034
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 31 YR
• Patient Weight: 75