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

Catalog Number	0035630
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Urinary Tract Infection (2120); Patient Problem/Medical Problem (2688)
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.The device was not returned.
Event or Problem Description
It was reported that two infant catheter kits were sent, received and used on one infant without the povidone-iodine included.Reportedly, as a result, the infant contracted a urinary tract infection.The uti was treated with antibiotics.It was noted that the yellow label indicating the absence of the povidone-iodine was adhered to the packaging.However, the nurse did not notice the label upon first looking at the package.
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: ¿product does not contain iodine.".
Event or Problem Description
It was reported that two infant catheter kits were sent, received and used on one infant without the povidone-iodine included.Reportedly, as a result, the infant contracted a urinary tract infection.The uti was treated with antibiotics.It was noted that the yellow label indicating the absence of the povidone-iodine was adhered to the packaging.However, the nurse did not notice the label upon first looking at the package.

• Brand Name: DAVOL® INFANT CATH KIT
• Common Device Name: INFANT CATHETER KIT
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8108877
• Report Number: 1018233-2018-05642
• Device Sequence Number: 1630604
• Product Code: FFH
• UDI-Device Identifier: 00801741045844
• UDI-Public: (01)00801741045844
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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,user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/18/2019

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2021
• Device Catalogue Number: 0035630
• Device Lot Number: NGCS1862
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/05/2018
• Supplement Date Received by Manufacturer: 01/02/2019
• Initial Report FDA Received Date: 11/27/2018
• Supplement Report FDA Received Date: 01/18/2019
• 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: Required Intervention