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

Model Number	086032
Health Effect - Clinical Codes	Death (1802); Hemorrhage/Blood Loss/Bleeding (1888); Liver Damage/Dysfunction (1954); Renal Failure (2041); Ulceration (2116)
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.The device was not returned.
Event or Problem Description
It was reported that a (b)(6) male was admitted to the hospital with an upper gastrointestinal bleed and esophageal varcies, which required blood transfusions and intubation.A nasogastric tube was not able to be placed in the patient due to epistaxis.The patient required a rectal tube for lactulose administration as needed to treat hepatic encephalopathy.A bardex malecot model drain, product catalog number 086032, was placed rectally in the patient on (b)(6) 2017 and was indwelling until it was removed on (b)(6) 2017.The reason for removal is unknown.A second malecot drain, with the same product catalog number, was placed on (b)(6) 2017 and removed on the same day due to an occlusion.On (b)(6) 2017, the patient developed a lower gastrointestinal bleed and a sigmoidoscopy was performed revealing an ulceration in an unknown area, which was the source of the bleeding.A hemostatic clip was placed to stop the bleeding.On (b)(6) 2017 an external fecal system was put in place on the patient for fecal management.The patient expired later in the month of november, however ,the exact date is unknown.The cause of death was liver failure.The patient had a history of renal failure and liver disease.Per review of the bard product insert, it is stated that this device is for urological use only.Per additional information received.The ulceration was at the anorectal area.
Additional Manufacturer Narrative
The reported event was confirmed as use-related based on the given event description provided by the user.No sample was returned for evaluation.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use state the following: ¿bard urological catheter 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.For urological use only.Manufactured in u.S.A.Packaged in mexico 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.Caution: contains or presence of natural rubber latex sterilized by ethylene oxide do not use if package is damaged.Single use only do not resterilize caution, consult accompanying documents.Warning: after use, this product may be a potential biohazard.Handle and dispose of in accordance with accepted medical practice and applicable laws and regulations.¿ (b)(4).The device was not returned.
Event or Problem Description
It was reported that a (b)(6) year-old male was admitted to the hospital with an upper gastrointestinal bleed and esophageal varcies, which required blood transfusions and intubation.A nasogastric tube was not able to be placed in the patient due to epistaxis.The patient required a rectal tube for lactulose administration as needed to treat hepatic encephalopathy.A bardex malecot model drain, product catalog number 086032, was placed rectally in the patient on (b)(6) 2017 and was indwelling until it was removed on (b)(6) 2017.The reason for removal is unknown.A second malecot drain, with the same product catalog number, was placed on (b)(6) 2017 and removed on the same day due to an occlusion.On (b)(6) 2017, the patient developed a lower gastrointestinal bleed and a sigmoidoscopy was performed revealing an ulceration in an unknown area, which was the source of the bleeding.A hemostatic clip was placed to stop the bleeding.On (b)(6) 2017 an external fecal system was put in place on the patient for fecal management.The patient expired later in the month of november, however ,the exact date is unknown.The cause of death was liver failure.The patient had a history of renal failure and liver disease.Per review of the bard product insert, it is stated that this device is for urological use only.Per additional information received.The ulceration was at the anorectal area.

• Brand Name: BARDEX® MALECOT MODEL DRAIN
• Common Device Name: BARDEX MALECOT MODEL DRAIN
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 7163961
• Report Number: 1018233-2018-00021
• Device Sequence Number: 1863449
• Product Code: FEW
• UDI-Device Identifier: 00801741023927
• UDI-Public: (01)00801741023927
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/12/2018

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: 10/31/2021
• Device Model Number: 086032
• Device Catalogue Number: 086032
• Device Lot Number: NGBP2484
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/11/2017
• Supplement Date Received by Manufacturer: 01/11/2018
• Initial Report FDA Received Date: 01/04/2018
• Supplement Report FDA Received Date: 01/12/2018
• 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
• Patient Age: 56 YR