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

Model Number 165816

Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemorrhage/Bleeding (1888); High Blood Pressure/ Hypertension (1908); Unspecified Infection (1930); Patient Problem/Medical Problem (2688)

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 that the patient experienced expulsions, blood spasms, a lot of bleeding, and infection within 48 hours of using the foley catheter.The patient was reportedly treated with antibiotics.Per additional information from the complainant on (b)(6) 2019, her son had leaking of urine and blood around the foley catheter, bladder spasms, and his blood pressure was elevated greater than 200's systolic and greater than 110 diastolic, approximately 48 hours after the catheter had been inserted.The complainant reports she is an experienced registered nurse and provides care for her non-verbal quadriplegic son, routinely changing his catheter every 30 days.She reports she recognized the symptoms and attributed them to autonomic dysreflexia then immediately acted to remove the catheter and replace it.The complainant reported she started antibiotics, as she has them on hand, as prescribed by the physician, for signs and symptoms indicative of infection.Upon removal of the catheter and with replacement of a new catheter, the symptoms started to improve.

Event Description

It was reported that the patient experienced expulsions, blood spasms, a lot of bleeding, and infection within 48 hours of using the foley catheter.The patient was reportedly treated with antibiotics.Per additional information from the complainant on (b)(6) 2019, her son had leaking of urine and blood around the foley catheter, bladder spasms, and his blood pressure was elevated greater than 200's systolic and greater than 110 diastolic, approximately 48 hours after the catheter had been inserted.The complainant reports she is an experienced registered nurse and provides care for her non-verbal quadriplegic son, routinely changing his catheter every 30 days.She reports she recognized the symptoms and attributed them to autonomic dysreflexia then immediately acted to remove the catheter and replace it.The complainant reported she started antibiotics, as she has them on hand, as prescribed by the physician, for signs and symptoms indicative of infection.Upon removal of the catheter and with replacement of a new catheter, the symptoms started to improve.It was later reported on 01nov2019, that when the catheter was changed, there were long, thin blood clots in the urine day bag.Urine was cloudy with medium to heavy sediment.

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 were found adequate and state the following: ¿sterile: unless package is opened or damaged.Warning: do not use ointments or lubricants having a petrolatum base.They will damage silicone and may cause balloon to burst.Caution: do not aspirate urine through drainage funnel wall.Storage: store catheters at room temperature away from direct exposure to light, preferably in the original box.Single use only.Do not reuse.Do not resterilize.For urological use only.Valve type: use luer slip syringe.Do not use needle.Recommended inflation capacities 3cc balloon: use 5ml sterile water 5cc balloon: use 10ml sterile water 30cc balloon: use 35ml sterile water do not exceed recommended capacities.Warning: after use, this product may be a potential biohazard.Handle and dispose of in accordance with applicable local, state, and federal laws and regulations.Note: aggressive traction, particularly in the presence of suturing, is not recommended for 100% silicone foley catheters." the device was not returned.

• Brand Name: BARDEX® ALL-SILICONE FOLEY CATHETER
• Type of Device: FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9255876
• MDR Text Key: 167972109
• Report Number: 1018233-2019-06938
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 00801741029752
• UDI-Public: (01)00801741029752
• Combination Product (y/n): N
• PMA/PMN Number: K040504
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 11/06/2019

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2023
• Device Model Number: 165816
• Device Catalogue Number: 165816
• Device Lot Number: NGCT2223
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/11/2019
• Initial Date FDA Received: 10/30/2019
• Supplement Dates Manufacturer Received: 10/30/2019
• Supplement Dates FDA Received: 11/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention