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

Model Number	086034
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Ulceration (2116); Ulcer (2274)
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 device was not returned.
Event or Problem 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.
Additional 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 or Problem 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
• Common Device Name: BARDEX MALECDOT MODEL DRAIN
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8739158
• Report Number: 1018233-2019-03403
• Device Sequence Number: 1341857
• Product Code: FEW
• UDI-Device Identifier: 00801741023934
• UDI-Public: (01)00801741023934
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K070879
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/01/2019

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: Health Professional
• Device Model Number: 086034
• Device Catalogue Number: 086034
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/06/2019
• Supplement Date Received by Manufacturer: 07/15/2019
• Initial Report FDA Received Date: 06/27/2019
• Supplement Report FDA Received Date: 08/01/2019
• 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
• Patient Age: 31 YR
• Patient Weight: 75