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

Catalog Number	0035720
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/18/2025
Type of Reportable Event	Serious Injury
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 catheter was separated from female catheter kit collection tubing.Catheter was stuck in patient for multiple days and needed to be surgically removed.
Additional Manufacturer Narrative
The reported event was inconclusive because no sample was available for evaluation and further investigation did not result in any additional findings.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 state the following: 1.Open package and remove plastic wallet.2.Open plastic wallet and don gloves.3.Pull catheter out of tube to desired length.Lay tube on sterile field.4.Open lubricant and lubricate catheter.5.Open swab packet.Cleanse vaginal area.6.Proceed with catheterization.7.Pull catheter out of top; tighten cover and depress blue spout.8.Fill out label, place on centrifuge tube.Send to lab in normal manner.Important: 1.Use plastic wallet as sterile field.2.Pull catheter out of centrifuge tube to the proper length immediately after donning gloves.Note: if urine does not flow freely into the tube, the cap may need to be loosened slightly.Correction: d, g.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 catheter was separated from female catheter kit collection tubing.Catheter was stuck in patient for multiple days and needed to be surgically removed.
Additional Manufacturer Narrative
The reported event was inconclusive because the 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 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 state the following: 1.Open package and remove plastic wallet.2.Open plastic wallet and don gloves.3.Pull catheter out of tube to desired length.Lay tube on sterile field.4.Open lubricant and lubricate catheter.5.Open swab packet.Cleanse vaginal area.6.Proceed with catheterization.7.Pull catheter out of top; tighten cover and depress blue spout.8.Fill out label, place on centrifuge tube.Send to lab in normal manner.Important: 1.Use plastic wallet as sterile field.2.Pull catheter out of centrifuge tube to the proper length immediately after donning gloves.Note: if urine does not flow freely into the tube, the cap may need to be loosened slightly.Correction: e.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 catheter was separated from female catheter kit collection tubing.Catheter was stuck in patient for multiple days and needed to be surgically removed.

• Brand Name: DAVOL® FEMALE CATH KIT
• Common Device Name: FEMALE CATH 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 30014 ; 7707846100
• MDR Report Key: 21536181
• Report Number: 1018233-2025-01496
• Device Sequence Number: 7735911
• Product Code: FFH
• UDI-Device Identifier: 00801741045837
• UDI-Public: (01)00801741045837(11)241101(17)270831(10)NGJW3649
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Followup
• Report Date (Section B): 04/25/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 0035720
• Device Lot Number: NGJW3649
• 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: 02/18/2025
• Supplement Date Received by Manufacturer: 03/12/2025; 04/25/2025
• Initial Report FDA Received Date: 03/06/2025
• Supplement Report FDA Received Date: 03/19/2025; 04/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/01/2024
• 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: Required Intervention
• Patient Sex: Female