MAUDE Adverse Event Report: BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER; INTRAVASCULAR CATHETER

Model Number 381823

Device Problem Free or Unrestricted Flow (2945)

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

Event Date 08/25/2021

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 bd insyte¿ autoguard¿ shielded iv catheter had air in catheter.The following information was provided by the initial reporter, translated from (b)(6): "air draws from the indwelling needle the event that air is drawn from the connection between the indwelling needle and the catheter".

Manufacturer Narrative

H6: investigation summary: our quality engineer inspected the sample and photographs submitted for evaluation.Bd received one catheter adapter assembly, two miscellaneous extension sets, and two 10ml syringes.Four photos were also received.An investigation was only performed on the catheter adapter assembly as the other devices were not manufactured by bd.Air bubbles may occur due to leakage of the device during a draw or poor connection due to damaged component.A visual inspection of the catheter adapter assembly was performed and no damage was found.A leak test was then performed and no leakage occurred.As no leakage or damage was observed, bd was unable to confirmed the reported defect.A device history record review showed no non-conformances associated with this issue during the production of this batch.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.

Event Description

It was reported bd insyte¿ autoguard¿ shielded iv catheter had air in catheter.The following information was provided by the initial reporter, translated from japanese: "air draws from the indwelling needle the event that air is drawn from the connection between the indwelling needle and the catheter".

• Brand Name: BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER
• Type of Device: INTRAVASCULAR CATHETER
• MDR Report Key: 12595990
• MDR Text Key: 275425646
• Report Number: 1710034-2021-00870
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903818235
• UDI-Public: 00382903818235
• Combination Product (y/n): N
• PMA/PMN Number: K201075
• 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: 10/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 11/30/2021
• Device Model Number: 381823
• Device Catalogue Number: 381823
• Device Lot Number: 8340856
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2021
• Date Manufacturer Received: 10/12/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/06/2018
• 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