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

Catalog Number	277714
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.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 intermittent catheter had white excoriated areas along the length of the catheter.They appeared as though they would break if they were used inside of a patient.They were not expired.Multiple lots were affected (lot # nggq3749 and lot# unk).
Event or Problem Description
It was reported that intermittent catheter had white excoriated areas along the length of the catheter.They appeared as though they would break if they were used inside of a patient.They were not expired.Multiple lots were affected (lot#nggq3749 and lot#unk).Per follow up via email on (b)(6) 2024, customer stated this affected their full supply of red catheters.The markings were discovered during routine nursing care and all products removed.No medical intervention was required.Device was replaced.Full supply of red catheters had white markings along the length of the catheters that looked similar to stretch marks.
Additional Manufacturer Narrative
The reported event was confirmed cause unknown.Visual evaluation of the returned photo sample noted one unopened (with original packaging), intermittent latex catheter.Visual inspection of the one photo sample noted that the red rubber latex intermittent catheter appeared to have degradation on the catheter and the catheter shaft.This does not meet specification which states the product or assembly must be free of visible, lose or etched foreign matter, solvent spills, hair, etc.No actions can be taken at this time since a root cause was not identified.A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.The instructions for use were found adequate and states the following: 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.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: 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 GA 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 20586335
• Report Number: 1018233-2024-06914
• Device Sequence Number: 6568188
• Product Code: KOD
• UDI-Device Identifier: 00801741034107
• UDI-Public: (01)00801741034107(11)220428(17)261031(10)NGGQ3749
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/07/2025

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: Health Professional
• Device Catalogue Number: 277714
• Device Lot Number: NGGQ3749
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/15/2024
• Supplement Date Received by Manufacturer: 02/08/2025
• Initial Report FDA Received Date: 11/01/2024
• Supplement Report FDA Received Date: 02/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/28/2022
• 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: Other
• Patient Sex: Unknown