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

Catalog Number	0035720
Medical Device Problem Code	Misassembled (1398)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pulmonary Infarction (2021)
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.
Event or Problem Description
It was reported that the gloves inside of the female catheter kit were not wrapped up in paper like they usually are, which caused the gloves to fall out of the tray onto a non-sterile surface once the tray was opened.Allegedly, this issue caused there to be catheter associated infections.There was no information available regarding the specific treatment provided.
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 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.".
Event or Problem Description
It was reported that the gloves inside of the female catheter kit were not wrapped up in paper like they usually are, which caused the gloves to fall out of the tray onto a non-sterile surface once the tray i was opened.Allegedly, this issue caused there to be catheter associated infections.There was no information available regarding the specific treatment provided.

• Brand Name: DAVOL® FEMALE CATH KIT
• Common Device Name: FEMALE CATHETER KIT
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8189542
• Report Number: 1018233-2018-06138
• Device Sequence Number: 2266881
• Product Code: FFH
• UDI-Device Identifier: 00801741045837
• UDI-Public: (01)00801741045837
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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,user facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/04/2019

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 Expiration Date: 04/30/2021
• Device Catalogue Number: 0035720
• Device Lot Number: NGCU3528
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/28/2018
• Supplement Date Received by Manufacturer: 01/16/2019
• Initial Report FDA Received Date: 12/21/2018
• Supplement Report FDA Received Date: 02/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other