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

Catalog Number 381423

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem No Information (3190)

Event Date 01/09/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.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 with the use of the bd insyte¿ autoguard¿ shielded iv catheter there was an issue with connector is too short for the connection tubing, not enough threads to attach to.

Event Description

It was reported with the use of the bd insyte¿ autoguard¿ shielded iv catheter there was an issue with connector is too short for the connection tubing, not enough threads to attach to.

Manufacturer Narrative

H.6.Investigation: review of the dhr one non-related qn was initiated that would impact the outcome of the quality of the product relevant to the defect stated.All required challenge samples, set-up and in process testing was performed in accordance with the quality plans.Received one unused iag 22ga unit in a sealed package with ¿not working¿ written on the package from catalog number 381423, lot number 8253952.In addition, received one unused iag 22ga unit in a sealed package with "working correctly" written on the package.From catalog number 381423, lot number 6179840.Visual/microscopic evaluation: both units have the same rib count both units have the same thread count water/air leak test: testing was performed using a lab supplied iso compatible male luer test fitting and iso compatible luer lock.Tested the catheter/adapter assembly; observed there was no leakage in any area of the connection.Functional test: a functional assessment of the connection compatibility of the returned catheter/adapter assemblies was conducted to evaluate the reported incident.A fluid test was performed by connecting an iso standard 10ml bd syringe and a red fluid/water mix.The fluid flowed through to the catheter tip.There was no leakage at the connection sites the defects adapter orientation incorrect and leakage could not be confirmed or replicated with the returned units.The were no changes in the design of the adapter.The material used to mold the adapter and the dimensions are same for both returned units.

• 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
• MDR Report Key: 8278985
• MDR Text Key: 134240427
• Report Number: 1710034-2019-00107
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903814238
• UDI-Public: 30382903814238
• Combination Product (y/n): N
• PMA/PMN Number: K952861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 03/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 08/31/2021
• Device Catalogue Number: 381423
• Device Lot Number: 8253952
• Date Manufacturer Received: 01/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other