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

Model Number 0035720

Device Problem Component Misassembled (4004)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/19/2022

Event Type  malfunction  

Event Description

It was reported that the swab sticks were dry and white as if the povidone-iodine solution had never been added.

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.

Manufacturer Narrative

The reported event was confirmed as supplier related.A potential root cause for this failure mode could be ¿incorrect line clearance".The device history record was reviewed and found nothing that could have caused or contributed to the reported event.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." h11: section a through f - the information provided by bard represents all of 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 bard.H3 other text : the actual/suspected device was inspected.

Event Description

It was reported that the swab sticks were dry and white, as if the povidone-iodine solution had never been added.

• Brand Name: DAVOL® FEMALE CATH KIT
• Type of Device: FEMALE 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 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 16090877
• MDR Text Key: 307809034
• Report Number: 1018233-2022-10147
• Device Sequence Number: 1
• Product Code: FFH
• UDI-Device Identifier: 00801741045837
• UDI-Public: (01)00801741045837
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 0035720
• Device Catalogue Number: 0035720
• Device Lot Number: NGGX4780
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/08/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female