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

Catalog Number 381823

Device Problem Break (1069)

Patient Problem Needle Stick/Puncture (2462)

Event Date 05/08/2020

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 a needle broke or detached causing a needle stick injury, which occurred after use with a bd insyte¿ autoguard¿ shielded iv catheter.The following information was provided by the initial reporter, "the hard needle is easy to fall off, causing the needle tack of the nurse's thigh.".

Manufacturer Narrative

H.6.Investigation summary the photo provided for this incident did not present sufficient evidence to identify or confirm the alleged failure or to establish a definite root cause as it only displayed the top web label.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 a needle broke or detached causing a needle stick injury, which occurred after use with a bd insyte¿ autoguard¿ shielded iv catheter.The following information was provided by the initial reporter, "the hard needle is easy to fall off, causing the needle tack of the nurse's thigh.".

• Brand Name: BD INSYTE¿ 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: 10090004
• MDR Text Key: 192150419
• Report Number: 1710034-2020-00335
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903818235
• UDI-Public: 382903818235
• Combination Product (y/n): N
• PMA/PMN Number: K952861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 06/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2022
• Device Catalogue Number: 381823
• Device Lot Number: 9326952
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other