MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE AUTOGUARD; PERIPHERAL IV CATHETERS

Catalog Number NS381834

Device Problem Retraction Problem (1536)

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

Event Date 02/18/2024

Event Type  malfunction  

Event Description

It was reported that bd insyte autoguard needle did not retract.The following information was provided by the initial reporter: needle without retraction after use.

Manufacturer Narrative

H.3.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.

Manufacturer Narrative

Investigation results: the complaint of retraction issues was confirmed from the two samples that were provided for investigation.The needle on the 1st sample failed to retract due to misplaced adhesive, which bonded the needle hub to the grip.This sample was confirmed for 'needle retraction failure'.During manufacturing, adhesive is dispensed into the hub to secure the cannula.Station misalignment may cause the adhesive to pour on the outside of the hub which can then flow in between the needle hub and the grip or the button.This may cause partial/slow/ or no retraction.A vision system software is in place to mitigate the occurrence of this defect.The needle on the 2nd sample was partially retracted, but the needle hub was caught on a damaged edge inside the shield at the interface of the barrel and grip.Since the safety mechanism was activated and the needle was partially retracted, the 2nd sample was confirmed for 'needle shielding failure'.During manufacturing, the barrel is seated to proper position.Improper machine set-up or misalignment may cause a damaged shield (grip/barrel) which may result in partial or no retraction.Machine 100% inspection and a quality control plan audit is performed to mitigate the occurrence of this defect.Both issues were manufacturing related and the appropriate manufacturing personnel were notified of this complaint.A trend was identified for needle retraction failure complaints.A capa and sa were opened to address this issue.This complaint type and corrective action will continue to be monitored for effectiveness.A notification of awareness has been sent to the manufacturing department.Complaints received for this device and reported condition will continue to be tracked and trended.

• Brand Name: BD INSYTE AUTOGUARD
• Type of Device: PERIPHERAL IV CATHETERS
• 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: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18918939
• MDR Text Key: 337856342
• Report Number: 1710034-2024-00192
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/18/2024

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 Catalogue Number: NS381834
• Device Lot Number: 3114871
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/25/2024
• Initial Date FDA Received: 03/16/2024
• Supplement Dates Manufacturer Received: 04/18/2024
• Supplement Dates FDA Received: 04/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/26/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1