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

Catalog Number	0035630
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/27/2017
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 packet of betadine swab leaked within the kit.
Event or Problem Description
It was reported that the packet of betadine swab leaked within the 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: "1.Open package and remove plastic wallet.2.Open plastic wallet.3.Place infant in supine position, thighs abducted.4.Cleanse the area around the meatus with povidone-iodine swabs.5.Put on sterile gloves.6.Place the tip of the catheter in sterile lubricant and catheterize patient.7.After urine is collected, pull catheter out of cap.8.Tighten cap and depress spout.9.Label centrifuge tube.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 packet of betadine swab leaked within the kit.
Additional Manufacturer Narrative
The reported issue (it was reported that the betadine swab pack had leaked within the kit) was confirmed, as supplier related.Visual inspection found that the supplier seal was opened.The seal delaminated one side of the package.The seal was opened and leaked iodine in product components.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: "1.Open package and remove plastic wallet.2.Open plastic wallet.3.Place infant in supine position, thighs abducted.4.Cleanse the area around the meatus with povidone-iodine swabs.5.Put on sterile gloves.6.Place the tip of the catheter in sterile lubricant and catheterize patient.7.After urine is collected, pull catheter out of cap.8.Tighten cap and depress spout.9.Label centrifuge tube.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." 1267, 2645: "nl".

• Brand Name: DAVOL® INFANT CATH KIT
• Common Device Name: INFANT CATH KIT
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 7231142
• Report Number: 1018233-2018-00287
• Device Sequence Number: 140154
• Product Code: FFH
• UDI-Device Identifier: 00801741045844
• UDI-Public: (01)00801741045844
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/21/2018

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: 12/31/2020
• Device Catalogue Number: 0035630
• Device Lot Number: NGBW2260
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2018
• Initial Date Received by Manufacturer: 01/11/2018
• Supplement Date Received by Manufacturer: 02/03/2018; 03/20/2018
• Initial Report FDA Received Date: 01/31/2018
• Supplement Report FDA Received Date: 02/07/2018; 03/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1