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

Model Number	800366
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Codes	Pain (1994); No Consequences Or Impact To Patient (2199); No Code Available (3191); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	12/24/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.
Event or Problem Description
It was reported that the catheter's balloon was unable to aspirate with syringe.Injected balloon port with 5cc sterile water and did not aspirate back.Then balloon port was cut and did not drain and 4.025 wire advanced length of foley and held in place, water from balloon port drained around wire then the catheter removed easily.
Additional Manufacturer Narrative
The reported event was inconclusive.No sample was returned for evaluation.A potential root cause for this failure could be manufacturing related due to operator error/ mechanical error/ thin rubberized layer.The lot number was unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: "to deflate catheter balloon: gently insert a 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.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 and adequately trained professional for assistance, as directed by hospital protocol." h11:section a through f - the information provided by bd 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 bd.
Event or Problem Description
It was reported that the catheter balloon was unable to aspirate with the syringe.The injected balloon port with 5cc sterile water would not aspirate back.Then the balloon port was cut and was unable to drain and 4.025 wire advanced the length of the foley held in place, the water from the balloon port drained around the wire then the catheter removed easily.
Event or Problem Description
It was reported that the catheter balloon was unable to aspirate with the syringe.The injected balloon port with 5cc sterile water would not aspirate back.Then the balloon port was cut and was unable to drain and 4.025 wire advanced the length of the foley held in place, the water from the balloon port drained around the wire then the catheter removed easily.Per medwatch report on 26aug2021, it was reported that a 18fr foley catheter was placed in the emergency department and it was removed by urology three days later in medical intensive care unit.It was stated that when they attempted to empty foley balloon with empty syringe, they were only able to get 4 ml out and the catheter was collapsing, it was unable to remove anymore.It was reported that they were unable to pull foley due to resistance and the patient complained of pain and the urology had to remove at bedside.No medical intervention was reported.
Additional Manufacturer Narrative
The reported event was inconclusive.No sample was returned for evaluation.Potential root cause for this failure mode could be user related (example: over aspirated, incorrect syringe/collapse lumen/sac close eye/valve damage).The lot number was unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: "caution: this product contains natural rubber latex which may cause allergic reactions.Sterile unless package is opened or damaged.Do not use if package is opened or damaged.Warning: on catheter, do not use ointments or lubricants having a petrolatum base.They will damage latex and may cause balloon to burst.Caution: do not aspirate urine through drainage funnel wall.Storage: store catheters at room temperature away from direct exposure to light, preferably in the original box.Note: after use, this product may be a potential biohazard.Handle and dispose of in accordance with accepted medical practice and applicable laws and regulations.Caution: federal (u.S.A.) law restricts this device to sale by or on the order of a physician.Single patient use only.Do not reuse.Do not resterilize.For urological use only.Valve type: use luer syringe.Do not use needle.Visually inspect the product for any imperfections or surface deterioration prior to use.Recommended inflation capacities: 3cc balloon: use 5cc sterile water.5cc balloon: use 10cc sterile water.15cc balloon: use 20cc sterile water.20cc balloon: use 25cc sterile water.30cc balloon: use 35cc sterile water.40cc balloon: use 45cc sterile water.75cc balloon: use 80cc sterile water.Do not exceed recommended capacities.To deflate catheter balloon: gently insert a 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.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 an 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." h11:section a through f - the information provided by bd 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 bd.
Additional Manufacturer Narrative
The reported event was inconclusive.Based on evaluation, the catheter deflated with no issue.As the inflation cap and valve was cut, it is unknown if the reported deflation issue was caused by the portion of the catheter that was removed.Therefore, the reported event will be inconclusive.It was unknown whether the product had caused the reported failure.A potential root cause for this failure could be thin rubberize wall that causing collapse/pinch inflation lumen under the balloon or along the shaft.The lot number was unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: "cdc guidelines for appropriate indications for indwelling urethral catheter use: patient has acute urinary retention or bladder outlet obstruction.Need for accurate urine output measurements.Use for selected surgical procedures.To assist in healing of open sacral or perineal wounds.Patient requires prolonged immobilization.To improve comfort for end of life care.Proper techniques for urinary catheter: insertion.Perform hand hygiene immediately before and after insertion.Insert urinary catheters using aseptic technique and sterile equipment.Use the smallest foley catheter possible, consistent with good drainage.Document the indications for catheter insertion, date and time of catheter insertion, individual who inserted catheter, and date and time of catheter removal in the patient record.Proper techniques for urinary catheter: maintenance: secure the foley catheter.Use the statlock® foley stabilization device if provided maintain a closed drainage system by utilizing pre-connected, sealed catheter-tubing junctions.Maintain unobstructed urine flow and keep the catheter and collection tube free from kinking.Keep the collection bag below the level of the bladder or hips at all times.Empty the collection bag regularly using a separate, clean collection container for each 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.
Event or Problem Description
It was reported that the catheter balloon was unable to aspirate with the syringe.The injected balloon port with 5cc sterile water would not aspirate back.Then the balloon port was cut and was unable to drain and 4.025 wire advanced the length of the foley held in place, the water from the balloon port drained around the wire then the catheter removed easily.Per medwatch report on 26aug2021, it was reported that a 18fr foley catheter was placed in the emergency department and it was removed by urology three days later in medical intensive care unit.It was stated that when they attempted to empty foley balloon with empty syringe, they were only able to get 4 ml out and the catheter was collapsing, it was unable to remove anymore.It was reported that they were unable to pull foley due to resistance and the patient complained of pain and the urology had to remove at bedside.No medical intervention was reported.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.Correction: d, e, f.H11: section a through f - the information provided by bd 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 bd.
Event or Problem Description
It was reported that the catheter balloon was unable to aspirate with the syringe.The injected balloon port with 5cc sterile water would not aspirate back.Then the balloon port was cut and was unable to drain and 4.025 wire advanced the length of the foley held in place, the water from the balloon port drained around the wire then the catheter removed easily.

• Brand Name: BARD® LUBRICATH® 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: yonic anderson ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 10877183
• Report Number: 1018233-2020-21127
• Device Sequence Number: 17094610
• Product Code: EZC
• UDI-Device Identifier: 00801741020131
• UDI-Public: (01)00801741020131
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K910846
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 12/16/2021

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
• Operator of Device: Health Professional
• Device Model Number: 800366
• Device Catalogue Number: 365718
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/29/2020
• Supplement Date Received by Manufacturer: 12/24/2020; 02/26/2021; 10/13/2021; 12/16/2021
• Initial Report FDA Received Date: 11/20/2020
• Supplement Report FDA Received Date: 01/15/2021; 03/23/2021; 11/02/2021; 12/17/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Required Intervention
• Patient Sex: Unknown