MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2018-01-04 for BARDEX? MALECOT MODEL DRAIN 086032 manufactured by C.r. Bard, Inc. (covington) -1018233.
[96360125]
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.
Patient Sequence No: 1, Text Type: N, H10
[96360126]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018233-2018-00021 |
| MDR Report Key | 7163961 |
| Report Source | OTHER |
| Date Received | 2018-01-04 |
| Date of Report | 2018-01-12 |
| Date Mfgr Received | 2018-01-11 |
| Device Manufacturer Date | 2017-03-10 |
| Date Added to Maude | 2018-01-04 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | AMY GRAVLEY |
| Manufacturer Street | 8195 INDUSTRIAL BLVD |
| Manufacturer City | COVINGTON GA 30014 |
| Manufacturer Country | US |
| Manufacturer Postal | 30014 |
| Manufacturer Phone | 7707846100 |
| Manufacturer G1 | C.R. BARD, INC. (COVINGTON) -1018233 |
| Manufacturer Street | 8195 INDUSTRIAL BLVD |
| Manufacturer City | COVINGTON GA 30014 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 30014 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BARDEX? MALECOT MODEL DRAIN |
| Generic Name | BARDEX MALECOT MODEL DRAIN |
| Product Code | FEW |
| Date Received | 2018-01-04 |
| Model Number | 086032 |
| Catalog Number | 086032 |
| Lot Number | NGBP2484 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | C.R. BARD, INC. (COVINGTON) -1018233 |
| Manufacturer Address | 8195 INDUSTRIAL BLVD COVINGTON GA 30014 US 30014 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-01-04 |