MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE AUTOGUARD PNK 20GA X 1.16IN; INTRAVASCULAR CATHETER

Catalog Number 381434

Device Problem Retraction Problem (1536)

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

Event Date 02/08/2024

Event Type  malfunction  

Manufacturer Narrative

H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Event Description

"it was reported that two bd insyte autoguard pnk 20ga x 1.16in needles' did not fully retract the needle.The following information was provided by the initial reporter: we¿re seeing a pattern with the safety mechanism on the 20ga insyte autoguards' not completely covering the end of the sharp after deployment.

Manufacturer Narrative

Investigation results: received one unsealed 20ga x 1.16in.Insyte autoguard unit from lot: 3251084.Additionally, 4 photos were provided.The photos provided do not display the same defect that was discovered in this investigation.The photos also show different lot numbers than from the unit that was physically provided.Visual inspection of the physical sample discovered that the unit was unsealed and used.The button was unable to be activated.Microscopic analysis discovered that there was adhesive that flowed between the needle hub and the grip.This may pour between the button and prevent any button activation or needle retraction.The reported defect was confirmed.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 appropriate manufacturing personnel were notified of this complaint.A device history record review showed no non-conformances associated with this issue during the production of this batch.Complaints received for this device and reported condition will continue to be tracked and trended.A trend was identified for needle retraction failure complaints and a capa was opened to address this issue.The implicated lot was manufactured after the implementation of the corrective actions.This complaint type and corrective action will continue to be monitored for effectiveness.Investigation conclusion(s): the defect of ¿needle retraction failure¿ was confirmed.Probable root cause(s): manufacturing.

Event Description

No additional information.

• Brand Name: BD INSYTE AUTOGUARD PNK 20GA X 1.16IN
• 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: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18869085
• MDR Text Key: 337256138
• Report Number: 1710034-2024-00168
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903814343
• UDI-Public: (01)00382903814343
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K201075
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/29/2024

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: 381434
• Device Lot Number: 3251084
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/20/2024
• Initial Date FDA Received: 03/08/2024
• Supplement Dates Manufacturer Received: 04/29/2024
• Supplement Dates FDA Received: 05/06/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/18/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1