MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. SEE H.10.; INTRAVASCULAR CATHETER

Model Number 382544

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 09/07/2021

Event Type  malfunction  

Manufacturer Narrative

Medical device brand name: bd insyte¿ autoguard¿ bc shielded iv catheter blood control technology 18ga 1.16in (1.3 x 30 mm).Investigation summary: our quality engineer inspected the photograph submitted for evaluation.Bd received one photo in black and white color.Visual inspection of the photo found that needle can be seen piercing the catheter tubing.The defect of needle through catheter was confirmed.Additionally there was black coloring on the distal end of the catheter and inside the needle tip, indicating that media was present on the device.Since the unit had been used and media was observed inside the unit, it is unlikely that the defect occurred during manufacturing as the device would have been received with the needle piercing through the catheter tubing, making a venipuncture attempt unlikely.A needle spear through may occur in the user setting during tip adhesion break, 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 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 that bd insyte¿ autoguard¿ bc shielded iv catheter blood control technology 18ga 1.16in (1.3 x 30 mm) had a needle through the catheter.The following information was provided by the initial reporter: "it was reported the plastic split away from the needle, no flashback".

• Brand Name: SEE H.10.
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 12703002
• MDR Text Key: 278540793
• Report Number: 1710034-2021-00918
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903825449
• UDI-Public: 30382903825449
• Combination Product (y/n): N
• PMA/PMN Number: K110443
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial
• Report Date: 10/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 10/31/2023
• Device Model Number: 382544
• Device Catalogue Number: 382544
• Device Lot Number: 0324417
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/28/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/19/2020
• 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