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

Catalog Number 382523

Device Problems Retraction Problem (1536); Device Dislodged or Dislocated (2923)

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

Event Date 10/10/2023

Event Type  malfunction  

Manufacturer Narrative

H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that bd bd insyte autoguard bc hub comes apart and the needle remains in the catheter.The following information was provided by the initial reporter: our nurses are having issues with the bd catheters - insyte autoguard bc - what type of information is needed to submit an inquiry.Specifically, when in initial process of use the blue casement comes apart and the draw needle stays in the clear holder.Per nursing blue casing casement splits apart during draw.F/u response 17 oct 2023 1.Date of event issue stated happened : (b)(6) 2023.2.Sample available/not available.3.Any adverse event or serious injury reported to patient or healthcare professional? none reported.4.Was there a delay of, or change in, the course of treatment due to the event? none that was mentioned other than getting another catheter to complete the process of use.

Manufacturer Narrative

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.After further review the as reported code was changed to "catheter releases prematurely" as customer reported the needle stays in clear housing and blue casement comes apart (releases).Based on the occurrence at the initial process of use, the device is unusable and therefore would not be mdr reportable.H3 other text : see narrative.

Event Description

No new information.

• 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: 18062035
• MDR Text Key: 327254673
• Report Number: 1710034-2023-01243
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903825234
• UDI-Public: (01)30382903825234
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110443
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 01/08/2024

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: Health Professional
• Device Catalogue Number: 382523
• Device Lot Number: 3164630
• Initial Date Manufacturer Received: 10/10/2023
• Initial Date FDA Received: 11/02/2023
• Supplement Dates Manufacturer Received: 01/08/2024
• Supplement Dates FDA Received: 01/09/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/13/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1