MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE AUTOG BC BLU 22GA X 1.0IN; INTRAVASCULAR CATHETER

Catalog Number 382523

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 03/25/2024

Event Type  malfunction  

Event Description

It was reported that bd insyte autog bc blu 22ga x 1.0in had foreign matter the following information was provided by the initial reporter: it was reported by customer that the item is #382523, lot #3192172 22g insyte auto guard with blood control catheters.I have stumbled upon probably 45 out of the 50 in the box that are leaking some type of greasy substance near the spring inside the needle retractor.Upon opening them, this substance gets all over your hands/gloves.I feel this is a pretty substantial patient safety and infection control problem.Some of the catheters are leaking so much of this substance that you can see the grease marks on the outside of the package.Also, not sure if it's related to this leaking substance, but this also jams up the button to retract the needle therefore the needle has a hard time retracting into the device posing another safety/infection risk of having an exposed/nonretractable used needle.I have several pictures of some of them we opened for demonstration purposes as well as a video of the jammed needle retractor button if you would like me to send those over as well.I have about 8 boxes of these same lot # catheters that i don't feel comfortable using on patients due to these issues, so i am not sure what to do about this.Verbatim: rcc received a complaint via email.Email(s) attached.The item is #382523, lot #3192172 22g insyte auto guard with blood control catheters.I have stumbled upon probably 45 out of the 50 in the box that are leaking some type of greasy substance near the spring inside the needle retractor.Upon opening them, this substance gets all over your hands/gloves.I feel this is a pretty substantial patient safety and infection control problem.Some of the catheters are leaking so much of this substance that you can see the grease marks on the outside of the package.Also, not sure if it's related to this leaking substance, but this also jams up the button to retract the needle therefore the needle has a hard time retracting into the device posing another safety/infection risk of having an exposed/nonretractable used needle.I have several pictures of some of them we opened for demonstration purposes as well as a video of the jammed needle retractor button if you would like me to send those over as well.I have about 8 boxes of these same lot # catheters that i don't feel comfortable using on patients due to these issues, so i am not sure what to do about this.

Manufacturer Narrative

H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.B3.The date received by manufacturer has been used for this field.

• Brand Name: BD INSYTE AUTOG BC BLU 22GA X 1.0IN
• 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: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 19130663
• MDR Text Key: 341463995
• Report Number: 1710034-2024-00339
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903825233
• UDI-Public: (01)00382903825233
• 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: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 382523
• Device Lot Number: 3192172
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/25/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/11/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1