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

Catalog Number 382512

Device Problem Defective Component (2292)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/17/2023

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 bd insyte¿ autoguard¿ bc shielded iv catheter tip was found jagged during use.The following information was provided by the initial reporter: yes, tip of catheter was jagged therefore unable to thread.Defect not noticed prior to iv start.Patient screamed in pain with initial stick, rn unable to thread therefore iv catheter was taken out.Patient developed a large hematoma and stated that had a been an extremely painful iv start.Second needle stick had to be done in order to start iv.

Manufacturer Narrative

H6: investigation summary: our quality engineer inspected the photographs submitted for evaluation.Bd received one photographs which displayed two product labels and one 24g insyte autoguard bc catheter.One of the labels is for a 24g x 0.75in.Insyte autoguard bc unit with lot number 2214515 which is addressed in this investigation.The other label is for a 22g x 1.00in.Insyte autoguard bc unit from lot number 2286182.A visual inspection of the photo showed that the catheter tip was potentially deformed; however, the photo does not provide enough detail to confirm this with certainty.It is possible that the appearance of a deformity is due to the angle of the picture.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.

Event Description

It was reported that the bd insyte¿ autoguard¿ bc shielded iv catheter tip was found jagged during use.The following information was provided by the initial reporter: "yes, tip of catheter was jagged therefore unable to thread.Defect not noticed prior to iv start.Patient screamed in pain with initial stick, rn unable to thread therefore iv catheter was taken out.Patient developed a large hematoma and stated that had a been an extremely painful iv start.Second needle stick had to be done in order to start iv.".

• 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
• Manufacturer (Section G): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 16325258
• MDR Text Key: 309155985
• Report Number: 1710034-2023-00074
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903825127
• UDI-Public: 00382903825127
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K201075
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 382512
• Device Lot Number: 2214515
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/03/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1