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

Catalog Number	0165SI16
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/26/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the foley catheter had holes in the tubing when registered nurse tested tubing before insertion.When the registered nurse tried to pull fluid out of the balloon the holes caused pressure in the tubing and the water would not drain.It could have caused harm to patient if it was not caught before insertion.It appeared the product was not saved and no patient harm occurred as it was caught before insertion on the patient.
Additional 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.H3 other text : the device was not returned.
Event or Problem Description
It was reported that the foley catheter had holes in the tubing when rn tested tubing before insertion.When the rn tried to pull fluid out of the balloon the holes caused pressure in the tubing and the water would not drain.It could have caused harm to patient if it was not caught before insertion.It appeared the product was not saved and no patient harm occurred as it was caught before insertion on the patient.
Additional Manufacturer Narrative
The reported event was inconclusive because no sample was returned.It was unknown whether the device had met relevant specifications.A potential root cause for this failure could be operator error, mechanical failure, user related (eg: use of sharp object).A review of the device history record did not show any problems or condition that would have contributed to the reported issue.The instructions for use were found adequate and states the following: warning: on catheter, do not use ointments or lubricants having a petrolatum base.They will damage the catheter and may cause balloon to burst.Warning: after use, this product may be a potential biohazard.Handle and dispose of in accordance with accepted medical practices and applicable local, state and federal laws and regulations.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.Please consult product label and insert for any indications, contraindications, hazards, warnings, cautions and directions for use.Proper techniques for urinary catheter maintenance: 1) secure the foley catheter.Use the statlock® foley stabilization device if provided.2) maintain a closed drainage system by utilizing pre-connected, sealed catheter-tubing junctions.3) maintain unobstructed urine flow and keep the catheter and collection tube free from kinking.4) keep the collection bag below the level of the bladder or hips at all times.5) empty the collection bag regularly using a separate, clean collection container for each.Foley catheter removal: 1) to deflate catheter balloon: gently insert a luer lock or slip tip syringe in the catheter valve.Never use more force than is required tomake the syringe ¿stick¿ in the valve 2) 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 3) use only gentle aspiration to encourage deflation if needed.Vigorous aspiration may collapse the inflation lumen, preventing balloon deflation 4) if the balloon will not deflate and 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 5) should balloon rupture occur, care should be taken to assure that all balloon fragments have been removed from the patient.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.

• Brand Name: BARDEX® I.C. 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: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 18169121
• Report Number: 1018233-2023-08272
• Device Sequence Number: 15390001
• Product Code: MJC
• UDI-Device Identifier: 00801741073793
• UDI-Public: (01)00801741073793
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K040658
• 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): 11/30/2023

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: Lay User/Patient
• Device Expiration Date: 09/30/2025
• Device Catalogue Number: 0165SI16
• Device Lot Number: NGHR0358
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2023
• Supplement Date Received by Manufacturer: 12/12/2023
• Initial Report FDA Received Date: 11/20/2023
• Supplement Report FDA Received Date: 12/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/18/2023
• 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: Female