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

Catalog Number	365716
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/04/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that foley catheter placed pre-operatively, balloon filled with 10 ml of saline from kit.As the physician was preparing to close the fascia, a request from same of back fill the bladder.Nurse prepared solution of normal saline and methylene blue (240 ml).They attached and introduced 60 ml using a luer lock syringe to the port on the drainage tube easily.The syringe refilled with 60 ml of solution attached and introduced solution, after approximately 15 ml nurse reported resistance.Surgeon and nurse heard a "pop" sound.At this time there was suspicion of rupture of the foley balloon.Foley catheter removed easily from urethra and noted the balloon not inflated and appeared to have a piece missing at the site of the balloon.Cystoscope was needed to remove a piece of the foley.Also stated that additional fluid was instilled to the bladder via sample port and not to the balloon.
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.
Event or Problem Description
It was reported that foley catheter placed pre-operatively, balloon filled with 10 ml of saline from kit.As the physician was preparing to close the fascia, a request from same of back fill the bladder.Nurse prepared solution of normal saline and methylene blue (240 ml).They attached and introduced 60 ml using a luer lock syringe to the port on the drainage tube easily.The syringe refilled with 60 ml of solution attached and introduced solution, after approximately 15 ml nurse reported resistance.Surgeon and nurse heard a "pop" sound.At this time there was suspicion of rupture of the foley balloon.Foley catheter removed easily from urethra and noted the balloon not inflated and appeared to have a piece missing at the site of the balloon.Cystoscope was needed to remove a piece of the foley.Also stated that additional fluid was instilled to the bladder via sample port and not to the balloon.
Additional Manufacturer Narrative
The reported event was confirmed ¿ cause unknown.The reported failure was able to be reproduced.The product was used for urological care.Evaluation confirmed the balloon was rupture.However, the exact cause of how and when the problem occurred could not be determined.The potential root cause for this failure could be user related (example: contact with sharp object)/ exposure to petrolatum based products/ mechanical failure/operator error).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: "insert foley catheters only for appropriate indications and leave in place only as long as needed.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 nd 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.Generally, drainage is accomplished by inserting the catheter through the urethra and into the bladder.However, drainage is sometimes accomplished by suprapubic or other placement of the catheter, such as nephrostomy tract." 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.

• 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: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 18011223
• Report Number: 1018233-2023-07670
• Device Sequence Number: 15300987
• Product Code: EZC
• UDI-Device Identifier: 00801741077746
• UDI-Public: (01)00801741077746
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/23/2023

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 Catalogue Number: 365716
• Device Lot Number: MYGX3560
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/06/2023
• Supplement Date Received by Manufacturer: 11/23/2023
• Initial Report FDA Received Date: 10/26/2023
• Supplement Report FDA Received Date: 11/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/05/2022
• 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