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

Catalog Number 381923

Device Problem Retraction Problem (1536)

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

Event Date 10/18/2021

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported bd insyte¿ autoguard¿ winged shielded iv catheter had a needle that would not retract.The following information was provided by the initial reporter, translated from (b)(6): "the needle does not return when the button is pressed.I tried to pull it out by pushing the puncture needle, but i did not return and removed it as it was.".

Event Description

It was reported bd insyte¿ autoguard¿ winged shielded iv catheter had a needle that would not retract.The following information was provided by the initial reporter, translated from japanese: "the needle does not return when the button is pressed.I tried to pull it out by pushing the puncture needle, but i did not return and removed it as it was.".

Manufacturer Narrative

H.6.Investigation: our quality engineer inspected the sample and photographs submitted for evaluation.Bd received one used un-retracted unit for investigation with a miscellaneous device on the needle tip.In addition, six photographs were received which displayed similarities to the returned unit.Upon inspection of the received unit, it was identified that the button has not been engaged.This likely indicates that the button has been damaged, or adhesive is present between the button and hub.A microscopic inspection of the needle hub and button found that adhesive is present on the outside of the hub and over the button tab.The reported issue was confirmed.This was physical/mechanical evidence to confirm and support a manufacturing process related issue for the reported defect.Adhesive on the outside of the hub may occur due to station or part misalignment or adhesive buildup on the nozzle.Dhr could not be performed due to unknown lot#.H3 other text : see h.10.

• Brand Name: BD INSYTE¿ AUTOGUARD¿ WINGED 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: 12829025
• MDR Text Key: 280940455
• Report Number: 1710034-2021-00987
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 11/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 381923
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/17/2021
• 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