MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 ALL SILICONE CATHETER; SILICONE FOLEY

Device Problems Biocompatibility (2886); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Stroke/CVA (1770); Death (1802); Hematuria (2558)

Event Date 03/11/2020

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 on (b)(6) 2020 that a patient developed gross hematuria after a silicone foley catheter was inserted.The catheter was inserted on (b)(6) 2020, prior to a cerebral angioplasty with embolization and the urine return was clear yellow at insertion.During the surgery, the operating room nurse noted bright red bloody urine in the drainage bag.After the surgery was completed, urology was consulted and ordered placement of a 3-way foley for irrigation of the bladder due to clots.The patient was not receiving any anticoagulants and had no known allergies.The nurse reported the patient expired later during the hospitalization due to other complications.Per additional information received from the complainant on (b)(6) 2020, the hematuria resolved without other intervention and was not considered a contributing factor to the patient's death.The nurse reported the (b)(6) year old male patient suffered a cerebrovascular accident (cva) and expired on (b)(6) 2020.The cause of death listed in the medical record was cva.The patient had a history of hypertension and hyperlipidemia.

Manufacturer Narrative

The device was not returned for evaluation.The reported event could not be confirmed.A potential failure mode could be ¿materials of construction are not biocompatible¿ with a potential root cause of ¿materials of construction are not biocompatible or immunological response on part of the patient¿.The lot number is unknown; therefore, a device history record could not be reviewed.Therefore, bard is unable to determine the associated labeling to review.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 on (b)(6)2020 that a patient developed gross hematuria after a silicone foley catheter was inserted.The catheter was inserted on (b)(6)2020 , prior to a cerebral angioplasty with embolization and the urine return was clear yellow at insertion.During the surgery, the operating room nurse noted bright red bloody urine in the drainage bag.After the surgery was completed, urology was consulted and ordered placement of a 3-way foley for irrigation of the bladder due to clots.The patient was not receiving any anticoagulants and had no known allergies.The nurse reported the patient expired later during the hospitalization due to other complications.Per additional information received from the complainant on (b)(6)2020 , the hematuria resolved without other intervention and was not considered a contributing factor to the patient's death.The nurse reported the 73 year old male patient suffered a cerebrovascular accident (cva) and expired on (b)(6) 2020.The cause of death listed in the medical record was cva.The patient had a history of hypertension and hyperlipidemia.

• Brand Name: ALL SILICONE CATHETER
• Type of Device: SILICONE FOLEY
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 10014766
• MDR Text Key: 191591147
• Report Number: 1018233-2020-02946
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• PMA/PMN Number: K040504
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Type of Report: Initial,Followup
• Report Date: 05/14/2020

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/10/2020
• Initial Date FDA Received: 04/30/2020
• Supplement Dates Manufacturer Received: 05/06/2020
• Supplement Dates FDA Received: 05/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR
• Patient Weight: 83