MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE AUTOGUARD BC SHIELDED IV CATHETER; INTRAVASCULAR CATHETER

Model Number 382634

Device Problem Leak/Splash (1354)

Patient Problem Laceration(s) (1946)

Event Date 04/29/2020

Event Type  malfunction  

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 the needle pierced through the bd insyte¿ autoguard¿ bc shielded iv catheter sheath during use while attempting to advance it.The following information was provided by the initial reporter: "i went tp place a 20g iv, iv needle slid across patient's skin, cutting his hand superficially, would not advance into the skin and poked out the side of the plastic iv catheter sheath.Removed and got a second iv which was places without incident.".

Manufacturer Narrative

H.6.Investigation summary : since no samples displaying the condition reported were available for examination, we were unable to fully investigate this incident.A device history record review showed no non-conformances associated with this issue during the production of this batch.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.H3 other text : see h.10.

Event Description

It was reported that the needle pierced through the bd insyte¿ autoguard¿ bc shielded iv catheter sheath during use while attempting to advance it.The following information was provided by the initial reporter: "i went tp place a 20g iv, iv needle slid across patient's skin, cutting his hand superficially, would not advance into the skin and poked out the side of the plastic iv catheter sheath.Removed and got a second iv which was places without incident.".

• Brand Name: BD INSYTE AUTOGUARD BC 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: 10070966
• MDR Text Key: 193431218
• Report Number: 1710034-2020-00313
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903826347
• UDI-Public: 30382903826347
• Combination Product (y/n): N
• PMA/PMN Number: K110443
• 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: 06/11/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2023
• Device Model Number: 382634
• Device Catalogue Number: 382634
• Device Lot Number: 0030450
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/29/2020
• Initial Date FDA Received: 05/19/2020
• Supplement Dates Manufacturer Received: 04/29/2020
• Supplement Dates FDA Received: 06/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 46 YR