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

Model Number	0166SI24
Medical Device Problem Code	Illegible Information (4050)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/24/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported event was inconclusive.No sample was returned for evaluation.It is unknown whether the device had met relevant specifications.The product was used for urological care.It was unknown whether the product had caused the reported failure.The potential root cause for this failure could be illegible print & missing print.The lot number was unknown; therefore, the device history record could not be reviewed.The product catalog number for this device is unknown.Therefore, bd is unable to determine the associated labeling to review.
Event or Problem Description
It was reported that the survey respondent mentioned that the instructions for use (ifu) did not provide sufficient information about the product and its medical application as they did not agree with the statement saying the instructions for use (ifu) for the following bard or becton dickinson product(s) provided sufficient information about the product(s) and their medical application(s) in relation to bardex i.C.2 way foley catheter (strip pack) (french size 24) and informed that in their opinion the ifu did not provide sufficient information about the product previously mentioned and its medical application because of inadequate or insufficient training, bardex i.C.2 way council tip foley catheter (strip pack) no french size specified and informed that in their opinion the ifu did not provide sufficient information about the product previously mentioned and its medical application because of missing information also stated that they was not able to successfully achieve hemostasis while using the large 30cc balloon because of neoplastic bleeding.
Additional Manufacturer Narrative
The reported event was inconclusive because no sample was returned.It is unknown whether the device had met relevant specifications.The product was used for urological care.It was unknown whether the product had caused the reported failure.The potential root cause for this failure could be illegible print & missing print.The device was not returned for evaluation.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state 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 to make 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 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.H3 other text : the device was not returned.
Event or Problem Description
It was reported that the survey respondent mentioned that the instructions for use (ifu) did not provide sufficient information about the product and its medical application as they did not agree with the statement saying the instructions for use (ifu) for the following bard or becton dickinson product(s) provided sufficient information about the product(s) and their medical application(s) in relation to bardex i.C.2 way foley catheter (strip pack) (french size 24) and informed that in their opinion the ifu did not provide sufficient information about the product previously mentioned and its medical application because of inadequate or insufficient training, bardex i.C.2 way council tip foley catheter (strip pack) no french size specified and informed that in their opinion the ifu did not provide sufficient information about the product previously mentioned and its medical application because of missing information also stated that they were not able to successfully achieve hemostasis while using the large 30cc balloon because of neoplastic bleeding.As per additional information received from ibc on 28nov2022, stated that the product that was associated not being able to achieve hemostasis was bardex 3-way irrigation foley catheter strip pack.

• 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: juan velez ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 15753906
• Report Number: 1018233-2022-08595
• Device Sequence Number: 20384258
• Product Code: MJC
• UDI-Device Identifier: 00801741016882
• UDI-Public: (01)00801741016882
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K910318
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Study
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/05/2023

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: Health Professional
• Device Model Number: 0166SI24
• Device Catalogue Number: 0166SI24
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/25/2022
• Supplement Date Received by Manufacturer: 01/05/2023
• Initial Report FDA Received Date: 11/08/2022
• Supplement Report FDA Received Date: 01/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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