MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDEX® LUBRICATH® FOLEY CATHETER TIEMANN MODEL COUDE; FOLEY CATHETER COUDE

Model Number 0102L16

Device Problems Deflation Problem (1149); Difficult to Remove (1528)

Patient Problems Urinary Retention (2119); 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 device was not returned.

Event Description

It was reported that a coude catheter was unable to deflate.Prior to insertion of the coude catheter, a return of urine was noted.During the procedure it was noted there was no urine output.Multiple attempts were made to remove the catheter.A urologist was able to remove the catheter with the balloon still inflated.After removal the balloon "spontaneously deflated.".

Manufacturer Narrative

The reported event was inconclusive as no sample was returned for evaluation.The potential root cause could be due to "kinked lumen" and "pinched lumen".The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: "to deflate catheter balloon: gently insert a luer slip tip syringe in the catheter valve.Never use more force than is required to make the syringe ¿stick¿ in the valve.Allow the pressure within the balloon to force the plunger back and fill the syringe with water.If you notice slow or no deflation, re-seat the syringe gently.Use only gentle aspiration to encourage deflation if needed.Vigorous aspiration may collapse the inflation lumen, preventing balloon deflation." 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.

Event Description

It was reported that a coude catheter was unable to deflate.Prior to insertion of the coude catheter, a return of urine was noted.During the procedure it was noted there was no urine output.Multiple attempts were made to remove the catheter.A urologist was able to remove the catheter with the balloon still inflated.After removal the balloon" spontaneously deflated".

• Brand Name: BARDEX® LUBRICATH® FOLEY CATHETER TIEMANN MODEL COUDE
• Type of Device: FOLEY CATHETER COUDE
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9415742
• MDR Text Key: 179127503
• Report Number: 1018233-2019-07732
• Device Sequence Number: 1
• Product Code: EZC
• UDI-Device Identifier: 00801741018121
• UDI-Public: (01)00801741018121
• Combination Product (y/n): N
• PMA/PMN Number: K910846
• 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: 01/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0102L16
• Device Catalogue Number: 0102L16
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 36 YR
• Patient Weight: 70