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

Model Number 119216M

Device Problems Deflation Problem (1149); Fluid/Blood Leak (1250); Component Missing (2306)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

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 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.The device was not returned.

Event Description

It was reported that the patient had scant urine output for the evening nurse.She assessed the foley catheter and found the catheter on the bed with the balloon deflated.The catheter was secured to the upper/inner thigh.The balloon was assessed and there was an attempt to inflate the balloon to see if it was defective.It in fact was.As soon as the balloon was being inflated, the balloon started squirting water and quickly deflated.It was later reported per additional information received from the complainant via email on 08jun2019, the catheter was inflated with 10ml water and no pieces were observed to be missing.

Event Description

It was reported that the patient had scant urine output for the evening nurse.She assessed the foley catheter and found the catheter on the bed with the balloon deflated.The catheter was secured to the upper/inner thigh.The balloon was assessed and there was an attempt to inflate the balloon to see if it was defective.It in fact was.As soon as the balloon was being inflated, the balloon started squirting water and quickly deflated.It was later reported per additional information received from the complainant via email on 08jun2019, the catheter was inflated with 10ml water and no pieces were observed to be missing.

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: ¿caution: federal (u.S.A.) law restricts this device to sale by or on the order of a physician.Sterile: unless package is opened or damaged.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.Recommended inflation capacities 8 fr.And 10 fr.(3cc balloon): use 3.5cc sterile water 12 fr.(5cc balloon): use 5.5cc sterile water 14 fr.And larger (5cc balloon): use 10cc sterile water do not exceed recommended capacities.Caution: aggressive traction, particularly in the presence of suturing, is not recommended for 100% silicone foley catheters.Warning: after use, this product may be a potential biohazard.Handle and dispose of in accordance with applicable laws and regulations.Warning: this product should never be connected to the temperature monitor or connected to a cable during an mri procedure.Failure to follow this guideline may result in serious injury to the patient.Refer to the instructions for use.It is important to closely follow these specific conditions that have been determined to permit the examination to be conducted safely.Any deviation may result in a serious injury to the patient." 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.

• Brand Name: BARDEX® LUBRI-SIL® ALL-SILICONE TEMP SENSING FOLEY CATHETER
• Type of Device: TEMP SENSING FOLEY
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8726537
• MDR Text Key: 148963004
• Report Number: 1018233-2019-03287
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 00801741046308
• UDI-Public: (01)00801741046308
• Combination Product (y/n): N
• PMA/PMN Number: K070582
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 07/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/09/2023
• Device Model Number: 119216M
• Device Catalogue Number: 119216M
• Device Lot Number: NGCY2104
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/03/2019
• Initial Date FDA Received: 06/24/2019
• Supplement Dates Manufacturer Received: 07/01/2019
• Supplement Dates FDA Received: 07/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1