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

Model Number 382523

Device Problem Retraction Problem (1536)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/20/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Investigation summary: since no samples displaying the condition reported were available for examination, we were unable to fully investigate this incident.A device history record review showed no non-conformances associated with this issue during the production of this batch.The reported defect could not be refuted nor confirmed in the absence of a sample.The root cause cannot be determined for an unconfirmed defect.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.Customer complaint trends are evaluated on a monthly basis, however the need for a formal corrective action cannot be determined in the absence of the root cause.

Event Description

It was reported that the bd insyte¿ autoguard¿ bc shielded iv catheter needle would not retract when placing an iv.The following information was provided by the initial reporter: "placed an iv and the needle would not retract.".

• Brand Name: BD INSYTE AUTOGUARD BC 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: 11387061
• MDR Text Key: 233968193
• Report Number: 1710034-2021-00142
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903825234
• UDI-Public: 30382903825234
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K110443
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 06/30/2023
• Device Model Number: 382523
• Device Catalogue Number: 382523
• Device Lot Number: 0196770
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/29/2021
• Initial Date FDA Received: 02/26/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/14/2020
• 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