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

Model Number 382523

Device Problem Retraction Problem (1536)

Patient Problems Exposure to Body Fluids (1745); Needle Stick/Puncture (2462)

Event Date 10/28/2022

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.Device manufacture date: unknown.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 while using bd insyte¿ autoguard¿ bc shielded iv catheter blood control technology the needle would not retract and a dirty needle stick occurred.The following information was provided by the initial reporter: nurse got stuck with a needle due to a malfunctioning iv device, the needle did not retract she went to occ health, they told her what to do with the patient, and sers was completed.

Manufacturer Narrative

H6: investigation summary our quality engineer inspected the sample submitted for evaluation.Bd received one needle in the barrel of an insyte autoguard unit.A gross visual inspection shows a unit that has been used and the needle retracted in the barrel.The barrel has some stress marks and has a slight bent near the rear end.The safety button has a crack, and it is fully engaged.In attempt to reproduce the issue of retraction failure, the needle was reengaged by pushing it out.The safety button was pushed, and the needle retracted but stopped at the bent on the barrel.The reported issue was confirmed.Although the reported issue was confirmed, it could not be determined if the damage resulted from the manufacturing of the device or from the user environment.Without the complete device, a full investigation could not be performed.This type of defect may occur during manufacturing due to a damaged barrel from machine misalignment.However, since the device has been handled, therefore this defect could have occurred in the used environment due to improper handling or storage condition.A device history review (dhr) cannot be performed as no lot number was provided by the complainant.Without the other part of the device to identify additional damages, the root cause cannot be determined with certainty.H3 other text : see h10.

Event Description

It was reported while using bd insyte¿ autoguard¿ bc shielded iv catheter blood control technology the needle would not retract and a dirty needle stick occurred.The following information was provided by the initial reporter: nurse got stuck with a needle due to a malfunctioning iv device, the needle did not retract she went to (b)(6) health, they told her what to do with the patient, and sers was completed.

• Brand Name: BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER BLOOD CONTROL TECHNOLOGY
• 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: 15859256
• MDR Text Key: 307775639
• Report Number: 1710034-2022-00728
• 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: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 382523
• Device Catalogue Number: 382523
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/31/2022
• Initial Date FDA Received: 11/23/2022
• Supplement Dates Manufacturer Received: 01/03/2023
• Supplement Dates FDA Received: 01/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Outcome(s): Required Intervention