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

Catalog Number 382533

Device Problem Material Puncture/Hole (1504)

Patient Problem Rupture (2208)

Event Date 07/21/2023

Event Type  malfunction  

Event Description

It was reported that while using the bd insyte¿ autoguard¿ bc shielded iv catheter the needle went throught the catheter.Report 1 of 2.The following was received by the initial reporter: update:the needle either penetrated the catheter.1st customer response: are you able to list the number of occurrences according to the issue? if yes, kindly provide the incident dates.Issue.No of occurrences.Incident dates.Needle through catheter.2.(b)(6) 2023.Did the needle penetrated the catheter in unit packaging or during insertion? both penetrated during insertion.What is the patient outcome? are there any adverse events/serious injuries? no serious injuries or adverse patient outcomes.Was there a needle stick injury? no needle stick injuries to staff members.

Manufacturer Narrative

H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that while using the bd insyte¿ autoguard¿ bc shielded iv catheter the needle went throught the catheter.Report 1 of 2.The following was received by the initial reporter: update:the needle either penetrated the catheter 1st customer response ¿ are you able to list the number of occurrences according to the issue? if yes, kindly provide the incident dates.Issue no of occurrences incident dates needle through catheter 2 (b)(6) 2023 & (b)(6) 2023 ¿ did the needle penetrated the catheter in unit packaging or during insertion? both penetrated during insertion.¿ what is the patient outcome? are there any adverse events/serious injuries? no serious injuries or adverse patient outcomes.¿ was there a needle stick injury? no needle stick injuries to staff members.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 21-sep-2023 h6: investigation summary bd received ten sealed 20 gauge insyte autoguard blood control units from lot 3121177 for evaluation.A review of the device history record was performed for the reported lot and no quality issues were found during production.Our quality engineer visually inspected the returned units and observed no visible defects or deformities.None of the needles had pierced through the catheter tubing or were already retracted.Next, the engineer broke each device's tip adhesion and activated the safety feature.Each unit retracted completely with no signs of resistance or delay.Each unit was found to be functional and within product specifications.Therefore, based off the visual inspection and testing the engineer was unable to verify the reported defect.Since no defects were found during inspection a definitive root cause could not be determined.H3 other text : see h10.

• Brand Name: BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER
• 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: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17484880
• MDR Text Key: 321159657
• Report Number: 1710034-2023-00889
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903825332
• UDI-Public: (01)00382903825332
• 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: 09/22/2023

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: 382533
• Device Lot Number: 3121177
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/24/2023
• Initial Date FDA Received: 08/08/2023
• Supplement Dates Manufacturer Received: 09/22/2023
• Supplement Dates FDA Received: 10/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2023
• 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