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

Model Number 381423

Device Problem Retraction Problem (1536)

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

Event Date 02/01/2023

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 at least 5 bd insyte¿ autoguard¿ shielded iv catheters had issues with the needle either not retracting, or retracting very slowly.The following information was provided by the initial reporter: "needle is not retracting or retracting very slowly.The mis-retraction and failures were not counted, however occurred to all of our 5 nurses in this department.No one was injured.".

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 21-feb-2023.Our quality engineer inspected the representative samples submitted for evaluation.Bd received 198 sealed 22ga x 1.00in.Insyte autoguard units from lot number 2284590.A sampling of 20 units were randomly chosen for needle retraction testing.All 20 units retracted fully and successfully but displayed a delay in retraction.The units should take 1 second or less to retract and all 20 units tested took longer than 1 second to retract.Further microscopic analysis discovered excess gel that went well below the coils.Gel is normal on units, but it generally does not flow too low below the coils.The reported issue of slow retraction was confirmed and determined to be manufacturing related due to excessive gel.This may occur due to an incorrect equipment setting.A quality control plan to check the weight at set-up is in place to mitigate the occurrence of this defect.A device history record review showed no non-conformances associated with this issue during the production of this batch.H3 other text : see h10.

Event Description

It was reported that at least 5 bd insyte¿ autoguard¿ shielded iv catheters had issues with the needle either not retracting, or retracting very slowly.The following information was provided by the initial reporter: "needle is not retracting or retracting very slowly.The mis-retraction and failures were not counted, however occurred to all of our 5 nurses in this department.No one was injured.".

• Brand Name: BD INSYTE¿ AUTOGUARD¿ 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 16441325
• MDR Text Key: 310246559
• Report Number: 1710034-2023-00146
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903814237
• UDI-Public: 00382903814237
• 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: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 381423
• Device Catalogue Number: 381423
• Device Lot Number: 2284590
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/18/2022
• 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