MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE AUTOGUARD STRAIGHT, 20G X 1.00"; INTRAVASCULAR CATHETER

Model Number 381433

Device Problems Defective Component (2292); Air/Gas in Device (4062)

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

Event Date 03/31/2022

Event Type  malfunction  

Event Description

It was reported that 2 bd insyte autoguard straight, 20g x 1.00" had defective adapters that caused air bubbles in the line.The following information was provided by the initial reporter: "in 2 of our patients, there were small holes within the pink plastic hub that connects the iv catheter to the iv line.This caused air to infiltrate into the iv line.".

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used as a default.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Manufacturer Narrative

Investigation: our quality engineer inspected samples submitted for evaluation.Bd received two hundred seventy-nine unopened units for investigation.A sample size of one hundred twenty-five units were pulled randomly and were tested for leakage.No leakage was observed in any of the units.The returned units provided for evaluation met and performed per the required manufacturing specifications.There was no physical/mechanical evidence to confirm and support a manufacturing process related issue for the failures stated in the report.A device history record review showed no non-conformances associated with this issue during the production of this batch.The complaint could not be confirmed and the root cause is undetermined.H3 other text : see h.10.

Event Description

It was reported that 2 bd insyte autoguard straight, 20g x 1.00" had defective adapters that caused air bubbles in the line.The following information was provided by the initial reporter: "in 2 of our patients, there were small holes within the pink plastic hub that connects the iv catheter to the iv line.This caused air to infiltrate into the iv line.".

• Brand Name: BD INSYTE AUTOGUARD STRAIGHT, 20G X 1.00"
• 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: 14177380
• MDR Text Key: 289900897
• Report Number: 1710034-2022-00207
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903814336
• UDI-Public: 00382903814336
• 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: 04/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 381433
• Device Catalogue Number: 381433
• Device Lot Number: 2014279
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/14/2022
• 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