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

Model Number	175810
Medical Device Problem Codes	Material Invagination (1336); Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/25/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when the user tried to remove the foley catheter bulb, it would not deflate fully which made the catheter to be lodged at the tip of the urethra.The patient was anesthetized, otherwise it would have been very painful.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The device was not returned.
Additional Manufacturer Narrative
The reported event was confirmed however the cause was unknown.One sample exhibited the reported failure.The device had not met specifications.The reported failure is considered out of specification as the reported failure was reproduced.The product was not used for patient treatment or diagnosis.The product caused the reported failure.Visual evaluation of the returned sample noted one opened (without original packaging), used two-way silicone pediatric foley catheter.Visual inspection of the sample noted no obvious visible defects.The catheter balloon was inflated with 5 ml methylene blue solution (3 drops 1% aq methylene blue per 100ml distilled water) and observed no leaks.The balloon rested without leaks and passively deflated in 1 minutes and 17.66 seconds with no issues.However, cuffing noted on the balloon upon deflation.This is out of specification per inspection procedure, which states, " balloon must not cuff after deflation.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: "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.If you notice slow or no deflation, re-seat the syringe gently.Allow the balloon to deflate slowly on its own.Do not aspirate or manually accelerate the deflation of the balloon.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." 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 or Problem Description
It was reported that when the user tried to remove the foley catheter bulb, it would not deflate fully which made the catheter to be lodged at the tip of the urethra.The patient was anesthetized, otherwise it would have been very painful.

• Brand Name: BARDEX® LUBRI-SIL® ALL-SILICONE FOLEY CATHETER
• Common Device Name: 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: juan velez ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 13563316
• Report Number: 1018233-2022-00731
• Device Sequence Number: 3788341
• Product Code: EZL
• UDI-Device Identifier: 00801741034282
• UDI-Public: (01)00801741034282
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K984084
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/25/2026
• Device Model Number: 175810
• Device Catalogue Number: 175810
• Device Lot Number: NGFU0622
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/27/2022
• Supplement Date Received by Manufacturer: 08/09/2022
• Initial Report FDA Received Date: 02/18/2022
• Supplement Report FDA Received Date: 08/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/26/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown