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

Model Number 0165SI16

Device Problems Deflation Problem (1149); Inaccurate Flow Rate (1249); Flushing Problem (1252); Material Separation (1562); No Flow (2991)

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 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.The device was not returned.

Event Description

It was reported that there was no urine draining from the foley catheter with recent output having increased sediment.The nurse attempted to flush the foley catheter and noticed a slit in the catheter near the entrance site where the foley was inserted into the patient's body, just outside the urethra.The nurse was unable to flush the catheter and was unable to remove the catheter as the balloon would not deflate.

Manufacturer Narrative

Received only catheter that has been cut at inflation funnel.The reported event could not be confirmed due to the poor sample condition.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: "warning: on catheter, do not use ointments or lubricants having petrolatum base.They will damage latex and may cause the balloon to burst.Caution: do not aspirate urine through drainage funnel wall.Recommended inflation capacities 3cc balloon: use 5cc sterile water 5cc balloon: use 10cc sterile water 30cc balloon: use 35cc sterile water do not exceed recommended capacities." 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 draining from the foley catheter with recent output having increased sediment.The nurse attempted to flush the foley catheter and noticed a slit in the catheter near the entrance site where the foley was inserted into the patient's body, just outside the urethra.The nurse was unable to flush the catheter and was unable to remove the catheter as the balloon would not deflate.

• Brand Name: BARDEX® I.C. 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: 7710805
• MDR Text Key: 114940404
• Report Number: 1018233-2018-02930
• Device Sequence Number: 1
• Product Code: MJC
• UDI-Device Identifier: 00801741016752
• UDI-Public: (01)00801741016752
• Combination Product (y/n): N
• PMA/PMN Number: K040658
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup
• Report Date: 09/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2022
• Device Model Number: 0165SI16
• Device Catalogue Number: 0165SI16
• Device Lot Number: 7LC7112
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2018
• Date Manufacturer Received: 09/03/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 60 YR