MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE AUTOGUARD BL 22GA X 1.0IN; INTRAVASCULAR CATHETER

Model Number 381823

Device Problem Leak/Splash (1354)

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

Event Date 07/26/2021

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.Device manufacture date: unknown.Investigation summary: our quality engineer inspected the sample and photographs submitted for evaluation.Bd received one used unit and three photos.Visual inspection of the returned sample found that there was damage present to the catheter tubing near the nose of the adapter.A leak test was performed and leakage was observed at the location of the described damage.Your reported defect was confirmed.Microscopic inspection of the unit found that there was a v-shaped cut on the catheter tubing.This type of damage is indicative of a needle spear through and would result in the observed leakage.Based on the event description that the unit was inserted in the patient, it is unlikely that the spear through originated during the manufacturing process as the device would be received with the needle piercing through the catheter tubing making a venipuncture attempt unlikely.A needle spear through may occur in the clinician setting during tip adhesion break or during venipuncture if the needle is advanced at a wrong angle or if the needle is moved up and down the catheter tubing.A device history record review could not be performed as the lot number is unknown.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 that bd insyte autoguard bl 22ga x 1.0in leaked.The following information was provided by the initial reporter: "this is a report about leakage with the use of insyte autoguard.".

• Brand Name: BD INSYTE AUTOGUARD BL 22GA X 1.0IN
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 12724561
• MDR Text Key: 280110651
• Report Number: 1710034-2021-00930
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903818235
• UDI-Public: 00382903818235
• 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
• Report Date: 10/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 381823
• Device Catalogue Number: 381823
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2021
• Date Manufacturer Received: 10/01/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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