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

Catalog Number 175812

Device Problems Material Puncture/Hole (1504); Failure to Infuse (2340)

Patient Problems Exposure to Body Fluids (1745); Discomfort (2330)

Event Date 01/30/2024

Event Type  Injury  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.H11: section a through f - the information provided by bd represents all 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.

Event Description

It was reported that the foley catheter balloon could not be inflated.The device handling hazards involved blood and/or body fluid contaminated and the patient experienced inconvenience.It was unknown what medical intervention was provided.

Manufacturer Narrative

The reported event was confirmed manufacturing related.Received 1 all silicone foley catheter.It was attempted to inflate the balloon with the inhouse syringe and 10 ml methylene blue solution (3 drops 1% aq methylene blue per 100ml distilled water), however it was immediately noted a hole in the catheter shaft measuring (0.022") and (0.0255") from the bifurcation.This is out of specification per inspection which states "catheter leaks, valve leaks, balloon perforation, lumen to lumen, prematurely deflated and dislodged balloon are not allowed, and must inflate and deflate with the use of a syringe." although a root cause could not be definitively identified, based on the risk documentation review, a potential root cause for this type of failure could be inserts with edges (operator hits the tube against the bottom insert when removing the piece from the mold).¿ 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: "description: bard® all-silicone foley catheters aid in clinical management by allowing for continuous drainage and measurement of urine.Indwelling urinary catheters or foley catheters can be used in patients of all ages.Up to 10 ch/fr is generally considered pediatric sizing, however, the appropriate size should be determined by the healthcare professional.Intended use: for urological use only.Indications: bard® all-silicone foley catheters are indicated for any clinical condition requiring drainage and/or collection and/or measurement of urine.Generally, drainage is accomplished by inserting the catheter through the urethra and into the bladder.Contraindication: no known contraindications.Caution: federal (u.S.A.) law restricts this device to sale by or on the order of a physician.Do not use device if package is opened or damaged.Do not aspirate urine through drainage funnel wall.This is a single use device.Do not resterilize any portion of this device.Reuse and/or repackaging may create a risk of patient or user infection, compromise the structural integrity and/or essential material and design characteristics of the device, which may lead to device failure, and/or lead to injury, illness, or death of the patient.Should balloon rupture occur, care should be taken to assure that all balloon fragments have been removed from the patient.Warnings: on catheter, do not use ointments or lubricants having a petrolatum base.It may cause balloon to burst.Instructions for use: visually inspect the product for any imperfections or surface deterioration prior to use.If package is opened or if any imperfection or surface deterioration is observed, do not use.Follow your facility protocol for catheter stabilization and urine collection.Insertion: 1.Wash hands.2.Use proper aseptic technique to prepare the patient for catheter insertion.3.Remove the catheter from wrap and lubricate the catheter.If hospital policy permits, it is possible to inject lubricant into the urethra.4.Catheterize the patient using dominant hand.5.When catheter tip has entered bladder, urine will flow through the catheter.A.For female, insert catheter 2 more inches (approximately 5 cm).B.For male, insert catheter all the way to bifurcation.6.Inflate the balloon with pre-filled water syringe if included.A.If pre-filled syringe is not included, then use a slip tip/luer lock syringe to fill catheter balloon with sterile water.Do not use needle.B.Do not exceed recommended capacities as stated on the inflation lumen of the catheter.7.Gently pull the catheter until the catheter balloon is snug against the bladder.Note: aggressive traction, particularly in the presence of suturing, is not recommended for 100% silicone foley catheters." h11: section a through f - the information provided by bd represents all 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 actual/suspected device was inspected.

Event Description

It was reported that the foley catheter balloon could not be inflated.The device handling hazards involved blood and/or body fluid contaminated and the patient experienced inconvenience.It was unknown what medical intervention was provided.Per additional information via email from ibc on 29mar2024, it was stated that the product had been placed in the care of the u of a hospital supply coordinators ((b)(6)) along with the packaging from what they remember.This was the only lot that we had issues with that they were aware of in the pediatric or.There was no additional impact to the patient from this incident.

• Brand Name: BARDEX® LUBRI-SIL® ALL-SILICONE FOLEY CATHETER
• Type of Device: SILICONE FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer (Section G): C.R. BARD INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 18739000
• MDR Text Key: 335755035
• Report Number: 1018233-2024-00853
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 00801741034145
• UDI-Public: (01)00801741034145
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K984084
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/06/2023
• Device Catalogue Number: 175812
• Device Lot Number: NGHP311
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/31/2024
• Initial Date FDA Received: 02/20/2024
• Supplement Dates Manufacturer Received: 05/09/2024
• Supplement Dates FDA Received: 05/10/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/20/2023
• 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