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

Model Number 0165SI12

Device Problems Partial Blockage (1065); Device Contamination with Chemical or Other Material (2944); No Flow (2991)

Patient Problem Urinary Retention (2119)

Event Date 08/24/2017

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 there was no urine outflow after placement.It was later reported that on (b)(6), the catheter was inserted into the patient at a ward, however no urine outflow was observed for about 3 hours after placement.Subsequently, the catheter was removed from the patient.At the facility the user performed testing on the distal tip of the removed catheter.The catheter was immersed in water and the user attempted to aspirate water using a syringe, but water was not aspirated.The user attempted a second trial.Water was aspirated with something white from the drainage lumen.

Event Description

It was reported that there was no urine outflow after placement.It was later reported that on aug.24, the catheter was inserted into the patient at a ward, however no urine outflow was observed for about 3 hours after placement.Subsequently, the catheter was removed from the patient.At the facility the user performed testing on the distal tip of the removed catheter.The catheter was immersed in water and the user attempted to aspirate water using a syringe, but water was not aspirated.The user attempted a second trial.Water was aspirated with something white from the drainage lumen.

Manufacturer Narrative

The reported event was unconfirmed.Received only the catheter for evaluation.No visual defects noted on returned catheter.Per the functional evaluation, the balloon was inflated with 10ml of water and administered flow rate testing.While inflated, the flow rate was 102ml/min, 103ml/min and 104ml/min.The internal flow specification for a sample of this product type is 100ml/min minimum, so the sample met the internal flow rate specification.Water was introduced thru the drainage eye and came out from drainage funnel without difficulty.Unable to duplicate reported event.The catheter was dissected and no conditions found that could have contributed to the reported event.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: "insert catheter into the urethral meatus and advance it until the balloon enters the bladder and urine flows out through the catheter.Using a syringe packaged in the tray, infuse the specified volume of sterile water into the inflation lumen to inflate the balloon." (b)(4).

• Brand Name: BARDEX® I.C. FOLEY CATHETER
• Type of Device: FOLEY CATHETER (LATEX)
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 6878864
• MDR Text Key: 87339845
• Report Number: 1018233-2017-04891
• Device Sequence Number: 1
• Product Code: MJC
• UDI-Device Identifier: 00801741016738
• UDI-Public: (01)00801741016738
• Combination Product (y/n): N
• PMA/PMN Number: K910318
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Type of Report: Initial,Followup
• Report Date: 02/24/2018

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: 01/11/2020
• Device Model Number: 0165SI12
• Device Catalogue Number: 0165SI12
• Device Lot Number: 7CG5062
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2017
• Initial Date Manufacturer Received: 08/28/2017
• Initial Date FDA Received: 09/20/2017
• Supplement Dates Manufacturer Received: 02/23/2018
• Supplement Dates FDA Received: 02/24/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1