MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 TEMPERATURE-SENSING FOLEY CATHETER; COUDE TIP BARD LATEX URETHRAL CATHETER

Catalog Number UNKNOWN

Device Problems Burst Container or Vessel (1074); Improper Flow or Infusion (2954)

Patient Problem No Information (3190)

Event Type  Injury  

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 a foley catheter would not drain unless the patient was sitting upright.While the rn was caring for the patient, both the patient and the rn heard a "pop".The patient stated it was the foley catheter balloon pop, the patient felt the pop.The rn attached a syringe to the balloon port and pulled back yellow urine in the syringe.The foley catheter was removed.The balloon had visibly popped.A cystoscope was not done on the patient to check for missing pieces.It is unknown how long the catheter had been in place.After the event, another catheter was replaced.

Manufacturer Narrative

The device was not returned for evaluation.The lot number is unknown; therefore, the device history record could not be reviewed.The product family for this foley catheter product is unknown.Therefore, bard is unable to determine the associated labeling to review.Because the product family is unknown, product catalog number 129416 instructions for use were evaluated.Product catalog number 129416 was selected for evaluation due to the relatively high volume of units manufactured.The instructions-for-use state the following: "caution: this product contains natural rubber latex which may cause allergic reactions.Caution: do not aspirate urine through drainage funnel wall.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.Caution: federal (u.S.A.) law restricts this device to sale by or on the order of a physician.Warning: on catheter, do not use ointments or lubricants having petrolatum base.They will damage latex and may cause the balloon to burst.Valve type: use luer slip syringe.Do not use needle.Sterile unless package is opened or damaged.Single patient use only.Do not reuse.Do not resterilize.For urological use only.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.Catheters should be replaced in accordance with the cdc guideline ¿guideline for prevention of catheter-associated urinary tract infection¿.At the onset or first signs of a urinary tract infection, catheter encrustation, or any other catheter-related adverse effect, the catheter should be replaced.As with all temperature probes, in the presence of rf energy sources, local heating, temperature errors, and probe damage may occur.In medical use, unplug the temperature sensing catheter at the temperature monitor before activating electrosurgical or other types of direct coupled rf energy sources.Storage: store catheters at room temperature away from direct exposure to light, preferably in the original box.Note: compatible with appropriate 400-series temperature monitors.Interchangeability + 0.2oc at 37oc.Do not stretch catheter.This will cause repositioning of probe.Do not use stylet.This will cause stretching of catheter.Do not exceed recommended capacities.Visually inspect the product for any imperfections or surface deterioration prior to use.Recommended inflation capacities 5cc balloon: use 10cc sterile water." (b)(4).The device was not returned.

Event Description

It was reported that a foley catheter would not drain unless the patient was sitting upright.While the rn was caring for the patient, both the patient and the rn heard a "pop".The patient stated it was the foley catheter balloon pop, the patient felt the pop.The rn attached a syringe to the balloon port and pulled back yellow urine in the syringe.The foley catheter was removed.The balloon had visibly popped.A cystoscope was not done on the patient to check for missing pieces.It is unknown how long the catheter had been in place.After the event, the catheter was replaced.

• Brand Name: TEMPERATURE-SENSING FOLEY CATHETER
• Type of Device: COUDE TIP BARD LATEX URETHRAL CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer Contact: amy gravley ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 7146311
• MDR Text Key: 95771122
• Report Number: 1018233-2017-06482
• Device Sequence Number: 1
• Product Code: MJC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K070582
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 01/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/04/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 53 YR