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

Catalog Number	0035380
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
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.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.The device was not returned.
Event or Problem Description
It was reported that the catheter was not draining urine after insertion in the correct anatomical placement.It was noted that another catheter was inserted and drained successfully.
Additional Manufacturer Narrative
The device was not returned for evaluation.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use state the following: "female cath kit with gloves and swabs.Instructions for use: open package and remove plastic wallet.Open plastic wallet and don gloves.Pull catheter out of tube to desired length.Lay tube in sterile field.Open lubricant and lubricate catheter.Open swab packet.Cleanse vaginal area.Proceed with catheterization.Pull catheter out of top; tighten cover and depress blue spout.Fill out label, place on centrifuge tube.Send to lab in normal manner.Important: use plastic wallet as sterile field.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." (b)(4).The device was not returned.
Event or Problem Description
It was reported that the catheter was not draining urine after insertion in the correct anatomical placement.It was noted that another catheter was inserted and drained successfully.
Additional Manufacturer Narrative
The reported event was unconfirmed.Received 1 unopened female catheter kit for evaluation.During the visual inspection no obvious defects were noticed in the sample.In order to verify the reported issue.Per functional assessment, the sample was found acceptable since water flowed through the catheter without any difficulty.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use state the following: "female cath kit with gloves and swabs instructions for use: 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 in 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." (b)(4).
Event or Problem Description
It was reported that the catheter was not draining urine after insertion in the correct anatomical placement.It was noted that another catheter was inserted and drained successfully.

• 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
• MDR Report Key: 6988615
• Report Number: 1018233-2017-05571
• Device Sequence Number: 10892400
• Product Code: FFH
• UDI-Device Identifier: 00801741045820
• UDI-Public: (01)00801741045820
• 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: distributor,other,user facili
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/12/2018

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 Expiration Date: 10/31/2020
• Device Catalogue Number: 0035380
• Device Lot Number: NGBS0871
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2017
• Initial Date Received by Manufacturer: 10/10/2017
• Supplement Date Received by Manufacturer: 11/13/2017; 02/09/2018
• Initial Report FDA Received Date: 10/30/2017
• Supplement Report FDA Received Date: 11/14/2017; 02/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1