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

Catalog Number	62608
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/17/2025
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.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.
Event or Problem Description
It was reported that the hydrosil catheter size had discrepancy.Per additional received on 23apr2025, parents struggled to pass the catheter on several occasions and noted size discrepancies with the catheters.Required multiple attempts to catheterise child due to issues with catheter, felt thinner catheter was difficult to pass.
Additional Manufacturer Narrative
The reported event is confirmed - manufacturing related.Photo: received one (1) photo sample.Photo sample showcases two (2) iscs outside of their packaging.Visual: received 2 hydrosil intermittent catheters.Verified material number 62608p and batch number jugn9131.Attempted to pass 8 fr/ch catheter into french gauge to determine size.Catheter was unable to go through french gauge number 8.9 fr/ch.Therefore, the product does not meet specifications.A labeling review is not required because labeling could not have prevented the reported failure.A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.Corrections: d, h.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.
Event or Problem Description
It was reported that the hydrosil catheter size had discrepancy.Per additional received on 23apr2025, parents struggled to pass the catheter on several occasions and noted size discrepancies with the catheters.Required multiple attempts to catheterize child due to issues with catheter, felt thinner catheter was difficult to pass.
Event or Problem Description
It was reported that the hydrosil catheter size had discrepancy.Per additional received on 23apr2025, parents struggled to pass the catheter on several occasions and noted size discrepancies with the catheters.Required multiple attempts to catheterize child due to issues with catheter, felt thinner catheter was difficult to pass.
Additional Manufacturer Narrative
The reported event is unconfirmed.Received one (1) photo sample.Photo sample showcases two (2) iscs outside of their packaging.Received 2 hydrosil intermittent catheters.Verified material number 62608p and batch number jugn9131.No nicks, burrs, bends, flash, bumps or sharps present.Measured values were obtained and compared to dwg241704 rev 5.Values measured are listed below.Based on acceptable criteria outlined obtained value meet specification.Therefore, product meets specifications.As the reported event is unconfirmed, a risk and labeling review is not required.A review of the device history record was not necessary due to the reported event being unconfirmed.Corrections: e, h.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.

• 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: 21960341
• Report Number: 1018233-2025-03224
• Device Sequence Number: 7310471
• Product Code: KOD
• UDI-Device Identifier: 00801741069130
• UDI-Public: (01)00801741069130(11)220209(17)261228(10)JUGN9131
• 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,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/05/2026

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: 62608
• Device Lot Number: JUGN9131
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2025
• Supplement Date Received by Manufacturer: 11/04/2025; 03/05/2026
• Initial Report FDA Received Date: 05/05/2025
• Supplement Report FDA Received Date: 11/06/2025; 03/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/09/2022
• 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