MAUDE Adverse Event Report: C.R. BARD INC. (COVINGTON) -1018233 PERSONAL CATHETER¿ INTERMITTENT CATHETER

Catalog Number	63612
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Codes	Discomfort (2330); Skin Tears (2516)
Date of Event	09/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, when handling the intermittent catheters, it was found most often that a slight slit in the skin to the fingers.On closer examination it was found the edges of the sleeves had tiny serrations, similar to a file or extremely fine craft saw, knife blade.It was razor sharp and not easy to avoid touching when opening to use, or to pack the catheters away for disposal.User found the usage very spiteful and uncomfortable to the hands.Co-incidentally, this had only occurred since the change from green to blue boxes containing 30 catheters.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.This report references a us equivalent device.The us udi equivalent for this product number is used.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 inconclusive because this investigation did not result in any additional findings and no sample was available for evaluation.The reported event is addressed within the labeling as it states".Precautions: do not use device if package is opened or damaged.Inspect the catheter before use.Do not use the device if damaged.If you have any clinical concerns with the use of this device for your condition, please contact your healthcare physician.Users and/or patients within the european union, should report any serious incident that has occurred in relation to the device to the manufacturer and the competent authority of the member state in which the user and/or patient is established.Users outside of the european union should report any serious incident that has occurred in relation to the device to the manufacturer and the regulatory authority of the country in which the user and/or patient is established." a review of the device history record did not show any problems or conditions that would have contributed to the reported issue.No additional actions can be taken at this time.Correction: d.This report references a us equivalent device.The us udi equivalent for this product number is used.H11: sections 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, when handling the intermittent catheters, it was found most often that a slight slit in the skin to the fingers.On closer examination it was found the edges of the sleeves had tiny serrations, similar to a file or extremely fine craft saw, knife blade.It was razor sharp and not easy to avoid touching when opening to use, or to pack the catheters away for disposal.User found the usage very spiteful and uncomfortable to the hands.Co-incidentally, this had only occurred since the change from green to blue boxes containing 30 catheters.No medical intervention was reported.

• Brand Name: PERSONAL CATHETER¿ INTERMITTENT CATHETER
• Common Device Name: INTERMITTENT CATHETER
• Manufacturer (Section D): C.R. BARD INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer (Section G): C.R. BARD INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 23156186
• Report Number: 1018233-2025-08622
• Device Sequence Number: 15997508
• Product Code: KOD
• UDI-Device Identifier: 00801741069284
• UDI-Public: (01)00801741069284(11)250419(17)300328(10)JUKQ1192
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K000723
• 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
• Report Date (Section B): 11/24/2025

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: Lay User/Patient
• Device Catalogue Number: 63612
• Device Lot Number: JUKQ1192
• 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: 09/23/2025
• Supplement Date Received by Manufacturer: 11/24/2025
• Initial Report FDA Received Date: 09/26/2025
• Supplement Report FDA Received Date: 12/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/19/2025
• 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