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

Model Number 381411

Device Problem Delivered as Unsterile Product (1421)

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

Event Date 10/07/2021

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.Device manufacture date: unknown.Investigation summary: one photo and one sample were received by our quality team for evaluation.Upon inspection, it was identified that the cover had been pierced and has multiple scratches.A device history record could not be evaluated as the lot number is unknown.Due to the force required to pierce the needle cover wall it is unlikely that the defect was caused in the clinical environment.The scratches are most likely from the customer removing the cover and placing it back as observed from the customer photo to the received condition.Improper setup of the vision system or a problem with the light intensity for the cameras is indicated to be a possible reason for this defect to slip through the established quality controls.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.

Event Description

It was reported that the bd insyte-n¿ autoguard¿ shielded iv catheter needle pierced through the cover.The following information was provided by the initial reporter: "needle was bent in packaging" via bd investigation: "the cover was also identified to have been pierced and has multiple scratches.".

• Brand Name: BD INSYTE-N¿ 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: 12822061
• MDR Text Key: 280948116
• Report Number: 1710034-2021-00986
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903814114
• UDI-Public: 00382903814114
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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
• Report Date: 11/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 381411
• Device Catalogue Number: 381411
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/12/2021
• 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