MAUDE Adverse Event Report: BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER; INTRAVASCULAR CATHETER

Catalog Number 381023

Device Problem Retraction Problem (1536)

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

Event Date 07/29/2021

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 that the bd insyte" autoguard" bc shielded iv catheter needle did not retract when the button was pressed.The following information was provided by the initial reporter, translated from (b)(6) to english: "according to the customer's report, the hcp pressed the button to activate the safety mechanism but the needle was not retracted.".

Event Description

It was reported that the bd insyte¿ autoguard¿ bc shielded iv catheter needle did not retract when the button was pressed.The following information was provided by the initial reporter, translated from japanese to english: "according to the customer's report, the hcp pressed the button to activate the safety mechanism but the needle was not retracted.".

Manufacturer Narrative

H6: investigation summary: four photos and one sample with an undamaged open package was received by our quality team for evaluation.Inspection of the sample showed that all components are present less the catheter adapter assembly.The photos showed various views of the unretracted iag bc unit.Visual observation reveal that the activation button is not depressed, and the needle is in the fully our position.Close examination found evidence of cured adhesive between the hub and the grip that hindered the button from being depressed and the retraction of the needle.Functional testing for needle retraction was conducted at which point the button would not depress therefore the needle did not retract as expected, thus confirming the reported defect.A review of the internal manufacturing device records and raw material history files for the reported lot numbers was performed and no recorded quality problems or rejections to this incident were found.During manufacturing at the adhesive dispense process, adhesive on outside of the hub, in the grip and/or the button can occur due to station misalignment and results in the needle retraction failure.Per the quality control plan, inspections for needle retraction and excessive adhesive are performed periodically during the manufacturing process that mitigates the occurrence of this defect.Preventative maintenance was conducted as scheduled with no deviations.A notification of this complaint was sent to the manufacturing department to raise awareness of this nonconformance.A review of the internal manufacturing device records and raw material history files for the reported lot numbers was performed and no recorded quality problems or rejections to this incident were found.

• Brand Name: BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER
• Type of Device: INTRAVASCULAR CATHETER
• MDR Report Key: 12443061
• MDR Text Key: 271330836
• Report Number: 1710034-2021-00790
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: K201075
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 09/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2023
• Device Catalogue Number: 381023
• Device Lot Number: 0335177
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2021
• Date Manufacturer Received: 09/09/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/30/2020
• 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