MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE AUTOGAURD; PERIPHERAL IV CATHETERS

Catalog Number 381511

Device Problems Corroded (1131); Device Contamination with Chemical or Other Material (2944)

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

Event Date 01/01/2024

Event Type  malfunction  

Manufacturer Narrative

H.3.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.

Event Description

It was reported that bd insyte autogaurd had rust.The following information was provided by the initial reporter: productcomplaint - insyte autoguard needles the plastic sheath (vialon) was discovered to be broken and looking rusting when they tried to insert the needle on a baby.No adverse event or injury.

Manufacturer Narrative

Additional information received indicating that there is no rust therefore the mdr was created in error and can be canceled.

Event Description

5 feb 2024 additional information received: this report is somewhat in error.I only reported that the catheter looked broken after attempting to use it.We did not see any rust on either catheter.We did attempt to use both catheters and noticed resistance not usually felt upon initial insertion, so stopped inserting them immediately.Once removed from baby, this is when we noticed the catheter was broken.My nnp and nurse both used the word ¿shredded¿ to describe it.

• Brand Name: BD INSYTE AUTOGAURD
• Type of Device: PERIPHERAL IV CATHETERS
• 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: 18641680
• MDR Text Key: 334562848
• Report Number: 1710034-2024-00067
• Device Sequence Number: 1
• Product Code: FOZ
• 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,Followup
• Report Date: 02/13/2024

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: Other
• Device Catalogue Number: 381511
• Device Lot Number: 3055706
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/09/2024
• Initial Date FDA Received: 02/05/2024
• Supplement Dates Manufacturer Received: 01/09/2024
• Supplement Dates FDA Received: 02/13/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/27/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1