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

Catalog Number 381867

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/29/2019

Event Type  malfunction  

Manufacturer Narrative

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 the bd insyte¿ autoguard¿ shielded iv catheter safety mechanism failed to activate and retract the needle during use.The following information was provided by the initial reporter: "safety mechanism not working: pressing the button the mechanism does not activate.".

Manufacturer Narrative

Bd received 11 insyte autoguard 14 gauge units from lot 8268611 for evaluation.One unit was received outside of its packaging and 10 units were received still inside the sealed packaging.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 physical/mechanical damage.The opened unit was fully retracted inside the safety barrel.The unit was reset and retraction was successful with no resistance felt.Next, the sealed units were inspected and no physical/mechanical damage was found.Functional retraction tests were performed on each unit and retraction was successful with no resistance.Based off the visual inspection and testing the engineer was unable to verify the reported defect.Since no defects were observed a definitive root cause could not be determined.

Event Description

It was reported that the bd insyte¿ autoguard¿ shielded iv catheter safety mechanism failed to activate and retract the needle during use.The following information was provided by the initial reporter: "safety mechanism not working: pressing the button the mechanism does not activate'.

• 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: 9316254
• MDR Text Key: 177386487
• Report Number: 1710034-2019-01218
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: K952861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 12/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2019
• 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: 381867
• Device Lot Number: 8268611
• Date Manufacturer Received: 10/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other