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

Model Number	0035380
Medical Device Problem Code	Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned for evaluation.A potential failure mode could be 'difficult insertion, urethral injury during insertion¿ with a potential root cause of 'outside diameter is too large, rough or irregular shape protrusions, catheter is too stiff due to wall thickness and material durometer rough or irregular shape protrusions.¿ the lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: "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.".
Event or Problem Description
It was reported that the catheter was rigid causing urethral trauma during insertion.

• 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: 9252087
• Report Number: 1018233-2019-06900
• Device Sequence Number: 14031301
• Product Code: FFH
• UDI-Device Identifier: 00801741045820
• UDI-Public: (01)00801741045820
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 10/29/2019

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 Model Number: 0035380
• Device Catalogue Number: 0035380
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2019
• Initial Report FDA Received Date: 10/29/2019
• 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