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 Incorrect Measurement (1383); Inadequacy of Device Shape and/or Size (1583); Obstruction of Flow (2423); Device Contamination with Chemical or Other Material (2944)

Patient Problems Fever (1858); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); No Consequences Or Impact To Patient (2199)

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 the urine was not draining into the drain bag.The patient experienced bleeding, infection and fever.There was a small rock looking material in the urine and customer assumes tat this was blocking the catheter.Also stated that the patient noticed white "worm" like strings 2 weeks ago but not as much now and felt the foley was shorter than all the others.The patient wanted it know that bd really needed to make longer foleys too.As per follow up on (b)(6) 2020, the customer noted that there was one catheter that was about an inch shorter than all the others.The customer reported that the difference in the length was clear when the patient tried to use it with the tube holder (competitor's version of statlock) because the patient had to adjust it on the leg.The catheter was no longer available for return.

Manufacturer Narrative

The reported event was inconclusive, as no sample returned for evaluation.A potential root cause for this failure mode could be due to ¿incorrect former selection or funnel trimmed too short.¿ it was unknown whether the device had met specifications.The product used for the treatment but it was unknown whether the product had caused the reported failure.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: 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.Storage: store catheters at room temperature away from direct exposure to light, preferably in the original box.Single patient use only.Do not reuse.Do not resterilize.For urological use only.Valve type: use luer slip tip syringe.Do not use needle.Recommended inflation capacities 3cc balloon: use 5ml sterile water 5cc balloon: use 10ml sterile water 15cc balloon: use 20ml sterile water 20cc balloon: use 25ml sterile water 30cc balloon: use 35ml sterile water 40cc balloon: use 45ml sterile water 75cc balloon: use 80ml 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.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.If permitted by hospital protocol, the valve arm may be severed.If this fails, contact adequately trained professional for assistance, as directed by hospital protocol.Should balloon rupture occur, care should be taken to assure that all balloon fragments have been removed from the patient.Visually inspect the product for any imperfections or surface deterioration prior to use.".

Event Description

It was reported that the urine was not draining into the drain bag.The patient experienced bleeding, infection and fever.There was a small rock looking material in the urine and customer assumes that this was blocking the catheter.Also stated that the patient noticed white "worm" like strings 2 weeks ago but not as much now and felt the foley was shorter than all the others.The patient wanted it know that bd really needed to make longer foleys too.As per the follow up on 28jul2020, the customer noted that there was one catheter about an inch shorter than all the others.The customer reported that the difference in the length was clear when the patient tried to use it with the tube holder (competitor's version of statlock) because the patient had to adjust it on the leg.The catheter no longer available for return.

• 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: 10431000
• MDR Text Key: 204341378
• Report Number: 1018233-2020-05297
• 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: consumer,other
• Type of Report: Initial,Followup
• Report Date: 09/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 0102L16
• Device Catalogue Number: 0102L16
• Device Lot Number: NGENX361
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1