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

Model Number 381834

Device Problem Defective Device (2588)

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

Event Date 08/24/2022

Event Type  malfunction  

Manufacturer Narrative

Date of event is unknown; awareness date has been used for this field.There were multiple lot numbers reported to be involved.The information for each additional lot number is as follows: medical device lot #: 2080983.Medical device expiration date: 28feb2025.Device manufacture date: 28mar2022.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 while using bd insyte autoguard pnk 20ga x 1.16in the connector could not be attached.There was no report of patient impact.The following information was provided by the initial reporter: catheter placed on a patient today.Screw thread failed: unable to screw in infusion.Use of the same batch as the faulty one but no screw thread problem.This problem occurred with batch 2012824 in (b)(6), but the device was not retained.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 13-oct-2022.H6: investigation summary bd received an unsealed 20 gauge insyte autoguard device from lot 2080983 for evaluation.No sample was received for lot 2012824, which was also reported to have been affected by this defect.A review of the device history record was performed for both reported lots and no quality issues were found at the time of manufacturing.Our quality engineer microscopically inspected the returned unit and observed some media inside of the catheter as well as some damage on the inside of the catheter on the screw thread.There was also some damage found on the outside of the adapter.An attempt was made to connect a syringe to the unit.The syringe was able to screw in properly but after a little bit of force was applied.However, due to the damage observed on the outside of the adapter the syringe failed to screw on completely.Therefore, based off the microscopic inspection and testing the engineer was able to verify the reported defect.It was determined that this was a manufacturing defect that occurred due to incorrect set up of the manufacturing equipment.

Event Description

It was reported while using bd insyte autoguard pnk 20ga x 1.16in the connector could not be attached.There was no report of patient impact.The following information was provided by the initial reporter: catheter placed on a patient today.Screw thread failed: unable to screw in infusion.Use of the same batch as the faulty one but no screw thread problem.This problem occurred with batch 2012824 in may, but the device was not retained.

• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15450943
• MDR Text Key: 306073385
• Report Number: 1710034-2022-00517
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903818341
• UDI-Public: 00382903818341
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K952861
• 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: 10/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 381834
• Device Catalogue Number: 381834
• Device Lot Number: 2012824
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/31/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/12/2022
• 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