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

Catalog Number 0035630

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017); Device Markings/Labelling Problem (2911)

Patient Problems Urinary Tract Infection (2120); Patient Problem/Medical Problem (2688)

Event Type  Injury  

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 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.

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 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
• Type of Device: INFANT CATHETER KIT
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8108877
• MDR Text Key: 128560550
• Report Number: 1018233-2018-05642
• Device Sequence Number: 1
• Product Code: FFH
• UDI-Device Identifier: 00801741045844
• UDI-Public: (01)00801741045844
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other,user facility
• Type of Report: Initial,Followup
• Report Date: 01/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2021
• Device Catalogue Number: 0035630
• Device Lot Number: NGCS1862
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention