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

Catalog Number 382533

Device Problem Defective Component (2292)

Patient Problems Pain (1994); Discomfort (2330)

Event Date 08/09/2023

Event Type  malfunction  

Event Description

It was reported while using bd insyte¿ autoguard¿ bc shielded iv catheter with blood control the catheter tip was deformed.This occurred 10 times.Report 1 of 2.The following information was provided by the initial reporter:.One nurse discovered the plastic at the end of the insyte are bulkier than the older ones.Response received 21 aug 2023.-the plastic was at the tip of the catheter.It was more thicker at the tip than any other location on the catheter.

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.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 29-aug-2023 h6: investigation summary bd received an unsealed 20 gauge insyte autoguard blood control unit from lot 3129117 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 unit and observed that the catheter tip was slightly deformed.Next, the engineer tested the returned unit for leakage but no leakage was observed.Therefore, based off the visual inspection and testing the engineer was able to verify the reported defect.It was determined that this was a manufacturing defect that occurred during the catheter tipping process.H3 other text : see h10.

Event Description

It was reported while using bd insyte¿ autoguard¿ bc shielded iv catheter with blood control the catheter tip was deformed.This occurred 10 times.Report 1 of 2.The following information was provided by the initial reporter:.One nurse discovered the plastic at the end of the insyte are bulkier than the older ones.Response received 21 aug 2023 -the plastic was at the tip of the catheter.It was more thicker at the tip than any other location on the catheter.

• Brand Name: BD INSYTE¿ AUTOGUARD¿ 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: 17637004
• MDR Text Key: 322109776
• Report Number: 1710034-2023-00951
• 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: 09/21/2023

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: 3129117
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/10/2023
• Initial Date FDA Received: 08/28/2023
• Supplement Dates Manufacturer Received: 09/21/2023
• Supplement Dates FDA Received: 10/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/11/2023
• 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