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

Catalog Number	0035720
Health Effect - Clinical Codes	No Patient Involvement (2645); 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 missing from the female catheter kit.
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: ¿bard female cath kit reorder/ref 0035720 8fr.Instructions for use: 1.Open package and remove plastic wallet.2 open plastic wallet and don gloves.3.Pull catheter out of the 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 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.Contents: ¿8fr.Catheter in centrifuge tube ¿povidone-iodine swabs ¿vinyl gloves ¿3 gm lubricant ¿towel ¿label sterilized by ethylene oxide single use.Do not resterilize.Do not use if package damaged.Not made with natural rubber latex.Caution: federal (u.S.A.) law restricts this device to sale by or on the order of the physician.Bard and davol are registered trademarks of c.R.Bard, inc." the device was not returned.
Event or Problem Description
It was reported that the catheter was missing from the female catheter kit.

• 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: 7804701
• Report Number: 1018233-2018-03699
• Device Sequence Number: 13830536
• Product Code: FFH
• UDI-Device Identifier: 00801741045837
• UDI-Public: (01)00801741045837
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/20/2018

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: 01/31/2021
• Device Catalogue Number: 0035720
• Device Lot Number: NGCR0118
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/30/2018
• Supplement Date Received by Manufacturer: 08/31/2018
• Initial Report FDA Received Date: 08/22/2018
• Supplement Report FDA Received Date: 09/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1