MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 DAVOL® PEDIATRIC CATH KIT; PEDIATRIC CATHETER

Catalog Number	0035640
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/08/2025
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.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 the pediatric catheter broke off, not sure if it was breaking off in the patients.
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.No actions can be taken at this time since a root cause was not identified.A dhr review is not required as the lot number is unknown.The instructions for use were found adequate and states the following: warnings: the catheter should never be forced if resistance is felt.Trauma to the bladder (false passage) can be prevented by adequately lubricating the catheter and stretching the penis to straighten the urethra.The following four steps apply only to male catheterization: place the tip of the catheter in sterile lubricant.Hold the penis perpendicular to the body to straighten the penile urethra and help prevent false passage.Advance the catheter carefully until urine appears.A slight resistance may be felt as the catheter passes the external sphincter.The following four steps apply only to female catheterization.Place the tip of the catheter in sterile lubricant.Spread the labia with two fingers and carefully advance the catheter until urine appears.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 the pediatric catheter broke off, not sure if it was breaking off in the patients.

• Brand Name: DAVOL® PEDIATRIC CATH KIT
• Common Device Name: PEDIATRIC 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: 22088778
• Report Number: 1018233-2025-03883
• Device Sequence Number: 6947588
• Product Code: FFH
• UDI-Device Identifier: 00801741045851
• UDI-Public: (01)00801741045851
• Combination Product (Y/N): Y
• Initial Reporter State: MI
• 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): 07/08/2025

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: 0035640
• 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: 05/08/2025
• Supplement Date Received by Manufacturer: 07/09/2025
• Initial Report FDA Received Date: 05/27/2025
• Supplement Report FDA Received Date: 07/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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