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

Model Number 381812

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

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

Event Date 09/27/2021

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 when using the bd insyte¿ autoguard¿ shielded iv catheter there was foreign matter on needle device.The following information was provided by the initial reporter.The customer stated: there was "a foreign body on the needle tip.".

Manufacturer Narrative

The following fields were updated due to additional information: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 11/16/2021.H.6.Investigation: our quality engineer inspected the sample submitted for evaluation.Bd received one unit within opened packaging.Upon visual inspection, a material was observed to be attached to the outside of the bevel of the needle and catheter tip.The reported defect was confirmed.Further inspection revealed the material to be translucent and flexible, matching catheter tubing material.Additionally, there were scratches and a gap at the inner wall near the tip.These findings were indicative of skiving, where the needle scrapes the inner wall of the catheter tubing; therefore, the material was confirmed to be a piece of catheter tubing.Skiving can originate from either manufacturing or by the user in the clinical setting.During manufacturing the defect of skiving may originate due to incorrect equipment settings.Preventative maintenance and visual inspections are performed at regular intervals to mitigate the risk from this type of defect.This defect can also occur during use if the clinician partially withdraws the needle and re-threads the catheter.As the unit had been removed from the packaging, bd was unable to determine which scenario was more likely.A device history record review showed no non-conformances associated with this issue during the production of this batch.

Event Description

It was reported when using the bd insyte¿ autoguard¿ shielded iv catheter there was foreign matter on needle device.The following information was provided by the initial reporter.The customer stated: there was "a foreign body on the needle tip.".

• 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
• Manufacturer (Section G): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12694134
• MDR Text Key: 278357567
• Report Number: 1710034-2021-00914
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903818129
• UDI-Public: 00382903818129
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K201075
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 09/30/2023
• Device Model Number: 381812
• Device Catalogue Number: 381812
• Device Lot Number: 0279674
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/07/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/05/2020
• 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