MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® RUBBER UTILITY CATHETER; INTERMITTENT CATHETER

Catalog Number	277716
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Codes	Tissue Breakdown (2681); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	12/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that patient used all purpose urethral catheters since 1998 when they had bladder cancer which was dealt with by an indiana pouch procedure.Patient catheterized at least 4 times per day and until recently their process has been uneventful.No infections and patient stoma have retained full functionality.Urologist monitored patient condition very carefully.Last week they noticed that there were traces of blood in their discharge.This was the first-time patient ever noticed anything out of the ordinary during a catheterization.They immediately call their physician and physician had them do an external exam which showed nothing wrong with patient stoma and physician had them do another insertion to see if the bleeding continued.Fortunately, it did not, and physician suggested continuing their routine.Patient did their morning routine and catheterized, using lube, as usual.Unfortunately, a small amount of blood appeared in their discharge.Upon withdrawal of the catheter patient felt a hang up that normally did not occur.A small amount of tissue was seen on the catheter which has never occurred before.Patient rinsed the catheter and felt a bubble approximately 1/2 way down on the 16in french catheter.See a bump and felt it as them run their fingers down the unit.A few hours later patient did another catheter procedure but this time they used a catheter for another case, they brought them in bulk from mark drug supply, and first checked for any abnormalities.No issues with hang up or bleeding occurred.Going forward patient would have to visually check before they use any of these units.This created sterile issues.Apparently, bard has a quality control issue and hopefully this was not a reoccurring issue as having tears or bleeding was a major issue to those of them who rely on this procedure to live a normal lifestyle.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.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 patient used all purpose urethral catheters since 1998 when they had bladder cancer which was dealt with by an indiana pouch procedure.Patient catheterized at least 4 times per day and until recently their process has been uneventful.No infections and patient stoma have retained full functionality.Urologist monitored patient condition very carefully.Last week they noticed that there were traces of blood in their discharge.This was the first-time patient ever noticed anything out of the ordinary during a catheterization.They immediately call their physician and physician had them do an external exam which showed nothing wrong with patient stoma and physician had them do another insertion to see if the bleeding continued.Fortunately, it did not, and physician suggested continuing their routine.Patient did their morning routine and catheterized, using lube, as usual.Unfortunately, a small amount of blood appeared in their discharge.Upon withdrawal of the catheter patient felt a hang up that normally did not occur.A small amount of tissue was seen on the catheter which has never occurred before.Patient rinsed the catheter and felt a bubble approximately 1/2 way down on the 16 in french catheter.See a bump and felt it as them run their fingers down the unit.A few hours later patient did another catheter procedure but this time they used a catheter for another case, they brought them in bulk from mark drug supply, and first checked for any abnormalities.No issues with hang up or bleeding occurred.Going forward patient would have to visually check before they use any of these units.This created sterile issues.Apparently, bard has a quality control issue and hopefully this was not a reoccurring issue as having tears or bleeding was a major issue to those of them who rely on this procedure to live a normal lifestyle.No medical intervention was reported.
Additional Manufacturer Narrative
The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be "rough or irregular shape protrusions".The device was not returned for evaluation.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: "x-ray opaque rubber.Warning: do not use ointments or lubricants having a petrolatum base.They will damage latex.This is a single use device.Do not resterilize any portion of this device.Reuse and/or repackaging may create a risk of patient or user infection, compromise the structural integrity and/or essential material and design characteristics of the device, which may lead to device failure, and/or lead to injury, illness or death of the patient.Visually inspect the product for any imperfections or surface deterioration prior to use.Storage: store catheters at room temperature away from direct exposure to light, preferably in the original box.Caution: this product contains natural rubber latex which may cause allergic reactions." 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.

• Brand Name: BARD® RUBBER UTILITY CATHETER
• Common Device Name: INTERMITTENT 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: 18409302
• Report Number: 1018233-2023-09311
• Device Sequence Number: 2690670
• Product Code: KOD
• UDI-Device Identifier: 00801741034114
• UDI-Public: (01)00801741034114
• Combination Product (Y/N): N
• Initial Reporter State: AK
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/12/2024

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: 277716
• Device Lot Number: NGHU0846
• 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: 12/10/2023
• Supplement Date Received by Manufacturer: 01/12/2024
• Initial Report FDA Received Date: 12/28/2023
• Supplement Report FDA Received Date: 01/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/16/2023
• 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