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

Catalog Number 382534

Device Problem Fitting Problem (2183)

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

Event Date 03/04/2024

Event Type  malfunction  

Manufacturer Narrative

E1.Address information was not provided, therefore, xx was used as a place holder.H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.

Event Description

It was reported the bd insyte autoguard bc 20g x 1.16in could not be connected to a mating component.The following information was provided by the initial reporter: when placing the iv the tubing pigtail would not thread on the hub.Patient stuck twice due to failure.One occurrence.

Manufacturer Narrative

Investigation results: the reported defect could not be refuted nor confirmed in the absence of a sample.The root cause cannot be determined for an unconfirmed defect.Dhr for lot number 3276443 has been reviewed.Subassembly lot 3276443 material 7000bcs34 was built and packaged on afa line 11 from 17oct2023 through 23oct2023 for a total quantity of (b)(4) units.No related quality issues or process deviations were found.This complaint type will continue to be trended within the post market surveillance process and any determined escalation will be managed there.

• Brand Name: BD INSYTE AUTOGUARD BC
• 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: 18934190
• MDR Text Key: 338070144
• Report Number: 1710034-2024-00199
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903825349
• UDI-Public: (01)00382903825349
• 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: 04/12/2024

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: 382534
• Device Lot Number: 3276443
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/04/2024
• Initial Date FDA Received: 03/19/2024
• Supplement Dates Manufacturer Received: 04/12/2024
• Supplement Dates FDA Received: 04/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/03/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1