MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 24 G X 0.56 IN. BD INSYTE-N¿ AUTOGUARD¿ SHIELDED IV CATHETER; INTRAVASCULAR CATHETER

Catalog Number 381411

Device Problem Insufficient Information (3190)

Patient Problem Staphylococcus Aureus (2058)

Event Date 01/14/2019

Event Type  Injury  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that an infant developed (b)(6) at the iv sit from where a 24 g x 0.56 in.Bd insyte-n¿ autoguard¿ shielded iv catheter was removed."baby developed (b)(6) in iv site 24 hours after removal.".

Manufacturer Narrative

Investigation summary: dhr - the lot number was built on afa line 4 from 25jun2017 thru 27jun2017.Packaged on packaging line 11 on 01jul2017.Review of dhr revealed all required challenge samples, set-up and in process testing was performed in accordance with the quality plans.The finish product testing results items passed per specifications.No quality notification were initiated during the build of this lot number.Received a 24ga unit within a sealed package from lot: 7170679.All contents within were intact.Visual examination: no damage was observed on areas the package received.The seal of the package was acceptable per specifications and sterility was not compromised.Water-leak test: the water leak was performed on the received package, no leakage was observed on any area.Indeterminate: the returned unit did not display any adverse characteristics that would contribute to the defect the customer experienced, and the failure described in the event description could not be replicated at the laboratory.

Event Description

It was reported that an infant developed mrsa at the iv sit from where a 24 g x 0.56 in.Bd insyte-n¿ autoguard¿ shielded iv catheter was removed."baby developed mrsa in iv site 24 hours after removal.".

• Brand Name: 24 G X 0.56 IN. BD INSYTE-N¿ AUTOGUARD¿ SHIELDED IV CATHETER
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 8324404
• MDR Text Key: 135677350
• Report Number: 1710034-2019-00163
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903814115
• UDI-Public: 30382903814115
• Combination Product (y/n): N
• PMA/PMN Number: K952861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Type of Report: Initial,Followup
• Report Date: 03/07/2019

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
• Device Operator: Other
• Device Expiration Date: 05/31/2020
• Device Catalogue Number: 381411
• Device Lot Number: 7170679
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2019
• Initial Date Manufacturer Received: 01/17/2019
• Initial Date FDA Received: 02/08/2019
• Supplement Dates Manufacturer Received: 01/17/2019
• Supplement Dates FDA Received: 03/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention