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

Catalog Number	0167L22
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/06/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was a small pin hole in the balloon, the balloons were deflating and coming out of the patient.(lot #nghx1678), (lot #nghw2924), (lot #nghv1207) per customer follow up received on 20may2024, it was reported that they experienced a deflated balloon which caused foley catheter to come out on 3 different occasions.They noticed a pin-sized hole in the balloon.Lot #nghv1207, lot #nghx1678, (lot #nghw2934) were reported and two of the catheters were discarded.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.
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 mode could be user related (example: contact with sharp object)/mechanical failure/operator error/thin rubberize layer).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 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.* 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." udi format updated with available product information per gudid.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 there was a small pin hole in the balloon, the balloons were deflating and coming out of the patient.(lot #nghx1678), (lot #nghw2924), (lot #nghv1207) per customer follow up received on 20may2024, it was reported that they experienced a deflated balloon which caused foley catheter to come out on 3 different occasions.They noticed a pin-sized hole in the balloon.Lot #nghv1207, lot #nghx1678, lot #nghw2934 were reported and two of the catheters were discarded.Per customer follow up received on 03jul2024, it was confirmed that the correct number for the affected lot is nghw2924.
Event or Problem Description
It was reported that there was a small pin hole in the balloon, the balloons were deflating and coming out of the patient.(lot #nghx1678, lot #nghw2924, lot #nghv1207).Per customer follow up received on 20may2024, it was reported that they experienced a deflated balloon which caused foley catheter to come out on 3 different occasions.They noticed a pin-sized hole in the balloon.Lot #nghv1207, lot #nghx1678, lot #nghw2934 were reported and two of the catheters were discarded.Per customer follow up received on 03jul2024, it was confirmed that the correct number for the affected lot is nghw2924.
Additional Manufacturer Narrative
Upon further review, bd has determined that this mdr was reported in error as it was found to be a duplicate of an event previously reported.Udi format updated with available product information per gudid.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® 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: 19407033
• Report Number: 1018233-2024-02996
• Device Sequence Number: 7049511
• Product Code: KOD
• UDI-Device Identifier: 00801741018978
• UDI-Public: (01)00801741018978(11)231027(17)270731(10)NGHW2924
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K922431
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/06/2024

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 Catalogue Number: 0167L22
• Device Lot Number: NGHW2924
• 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: 05/06/2024
• Supplement Date Received by Manufacturer: 07/30/2024; 08/29/2024
• Initial Report FDA Received Date: 05/28/2024
• Supplement Report FDA Received Date: 08/01/2024; 09/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/27/2023
• 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: Unknown