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

Catalog Number 165812

Device Problems Deflation Problem (1149); Physical Resistance (2578)

Patient Problem Death (1802)

Event Type  malfunction  

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.

Event Description

It was reported that the doctor was unable to deflate the balloon upon removal.Subsequently, the catheter was cut and removed.The catheter was placed in the urethra, on (b)(6) 2017, due to urine retention, at which time the patient complained of discomfort.After removal and inspection, it was noted that 6ml of water remained in the balloon.It was later reported that the doctor met resistance when trying to deflate the balloon.No injury was reported.The patient was able to independently pass urine; therefore the catheter was no longer need and was not replaced.The patient expired 1 day after the removal of the catheter due to unknown reasons.There was no allegation that the device contributed to the patient's death, as the patient was admitted for end of life care.Clinical statement: the patient's reported death was an incidental element of the patient's medical history and is unrelated to the reason for the complaint.There is no indication, report, or allegation that the device malfunction was related to the patient's death.

Manufacturer Narrative

The device was not 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: ¿for urological use only.Use a luer tip syringe.Inflate with stated ml of sterile water.Warning: do not use ointments or lubricants having a petrolatum base.They will damage silicone." 1528, 2119, 2330: "nl".(b)(4).

Event Description

It was reported that the doctor was unable to deflate the balloon upon removal.Subsequently, the catheter was cut and removed.The catheter was placed in the urethra, on (b)(6) 2017, due to urine retention, at which time the patient complained of discomfort.After removal and inspection, it was noted that 6ml of water remained in the balloon.It was later reported by the complainant, that the doctor met resistance when trying to deflate the balloon.No injury was reported.The patient was able to independently pass urine; therefore the catheter was no longer needed and was not replaced.The complainant reported that the patient expired 1 day after the removal of the catheter due to unknown reasons.The facility did not allege that the device contributed to the patient's death, as the patient was admitted for end of life care.Clinical statement: the patient¿s reported death was an incidental element of the patient¿s medical history and is unrelated to the reason for the complaint.There is no indication, report, or allegation that the device malfunction was related to the patient's death.

• Brand Name: BARDEX® ALL-SILICONE FOLEY CATHETER
• Type of Device: SILICONE FOLEY
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer Contact: amy gravley ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 6676424
• MDR Text Key: 78804269
• Report Number: 1018233-2017-03356
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K040504
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 09/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/30/2020
• Device Catalogue Number: 165812
• Device Lot Number: MYAQEA52
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/11/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1