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

Catalog Number	277714
Medical Device Problem Code	Component Misassembled (4004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/30/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient used intermittent catheter and they were unable to empty bladder at all.They looked at funnel end and noticed a white powder on it.They removed immediately and found that there was no hole in the inserted end which was the reason they were unable to empty bladder.Since they are supposed to be sterile, and they ensured that they were cleaned and sanitized before opening and using a catheter.
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.
Additional Manufacturer Narrative
The reported event was confirmed manufacturing related.A potential root cause for this failure mode could be "incorrect operation catheter not placed¿.Visual evaluation of the returned sample noted one opened (with original packaging), used all purpose urethral catheter.Visual inspection noted a white substance on the catheter funnel.They removed immediately and found that there was no eyelet at the inserted end of the catheter.This does not meet specification per inspection procedure states "missing/incorrect components are not allowed".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: "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.Caution: federal (usa) law restricts this device to sale by or on the order of a physician.For urological use only." correction: d.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 evaluated.
Event or Problem Description
It was reported that the patient used intermittent catheter and they were unable to empty bladder at all.They looked at funnel end and noticed a white powder on it.They removed immediately and found that there was no hole in the inserted end which was the reason they were unable to empty bladder.Since they are supposed to be sterile, and they ensured that they were cleaned and sanitized before opening and using a catheter.

• 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: 18474835
• Report Number: 1018233-2024-00031
• Device Sequence Number: 15151988
• Product Code: KOD
• UDI-Device Identifier: 00801741034107
• UDI-Public: (01)00801741034107
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2024

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: 277714
• Device Lot Number: NGHU3005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/26/2023
• Supplement Date Received by Manufacturer: 05/08/2024
• Initial Report FDA Received Date: 01/09/2024
• Supplement Report FDA Received Date: 05/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/24/2023
• 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