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

Catalog Number	0035640
Medical Device Problem Codes	Disconnection (1171); Fitting Problem (2183)
Health Effect - Clinical Code	Exposure to Body Fluids (1745)
Date of Event	09/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the customer stated that catheter kit has defect where the catheter falls out of the collection container during the procedure.This has caused urine to spill out of the container mid-collection, in one instance violated the sterile field, and has resulted in having to open several kits for some patients.They provided two lot number: ngjw2398 and ngjv1962.Customer response received via email on 16sept2025, it was reported that there was no patient impact, this was a concern that there was possibility to invite contamination based on prior experience and events.They were following the manufacturer¿s instructions for use, and it was failing, would lean towards pulling the product.They would be concerned for sensitive populations (newborns, immunocompromised) and risk of infection, in addition to the added discomfort."the catheter tubing was pulling free during the course of normal use.They just slip right out.This does impact the ability to use the product normally.".
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.
Additional Manufacturer Narrative
This supplemental mdr is being submitted to capture the investigation details.There were no health consequences or impact to the patient.This event is not reportable.Correction: f, h.The reported issue was confirmed; however, the root cause is unknown.Received 2 pediatric catheter kits in opened packaging.Verified material number 0035640 and batch numbers ngjv1962, ngjw2398.Visual inspection noted that the catheters were disconnected from the collection tube.Od measurements read: tube 1.09050in, cath 1.09020in, tube 2.09855in, cath 2 0.0950 in.This is out of specification, which states, product must conform to packaging drawing.Labeling was reviewed for this investigation.The labeling is found to be adequate.A review of the device history records did not show any problems or conditions that would have contributed to the reported issue.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 customer stated that catheter kit has defect where the catheter falls out of the collection container during the procedure.This has caused urine to spill out of the container mid-collection, in one instance violated the sterile field, and has resulted in having to open several kits for some patients.They provided two lot number ngjw2398 and ngjv1962.Customer response received via email on 16sept2025, it was reported that there was no patient impact, this was a concern that there was possibility to invite contamination based on prior experience and events.They were following the manufacturer¿s instructions for use, and it was failing, would lean towards pulling the product.They would be concerned for sensitive populations (newborns, immunocompromised) and risk of infection, in addition to the added discomfort."the catheter tubing was pulling free during the course of normal use.They just slip right out.This does impact the ability to use the product normally.".

• Brand Name: DAVOL® PEDIATRIC CATH KIT
• Common Device Name: PEDIATRIC CATHETER KIT
• 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: 23145099
• Report Number: 1018233-2025-08584
• Device Sequence Number: 21068851
• Product Code: FFH
• UDI-Device Identifier: 00801741045851
• UDI-Public: (01)00801741045851(11)241019(17)270731(10)NGJW2398
• 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): 12/15/2025

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
• Device Lot Number: NGJW2398
• 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: 09/10/2025
• Supplement Date Received by Manufacturer: 12/15/2025
• Initial Report FDA Received Date: 09/25/2025
• Supplement Report FDA Received Date: 12/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/19/2024
• 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