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

Model Number 381423

Device Problem Defective Component (2292)

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

Event Date 01/27/2023

Event Type  malfunction  

Event Description

It was reported that the bd insyte¿ autoguard¿ shielded iv catheter tip was serrated.The following information was provided by the initial reporter: "serrated at the end of it.Rigidness and not smooth.".

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¿ shielded iv catheter tip was serrated.The following information was provided by the initial reporter: "serrated at the end of it.Rigidness and not smooth.".

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 06-feb-2023.H6: investigation summary our quality engineer inspected the sample submitted for evaluation.Bd received one 22gx1.00in insyte autoguard device from lot number 2229934.A gross visual inspection displays a catheter with media indicating that it has been used.Further microscopic inspection shows a catheter with damage that has the v-shape form near the tip.The observed damage is identical to that created when the needle pierces the catheter wall near the tip giving a spear through.The reported issue was confirmed as the needle pierced through the catheter wall.Although the reported issue was confirmed, it could not be determined if the damage resulted from the manufacturing of the device or from the user environment.During manufacturing, this may occur due to a misalignment of the set together station, bent tubing, or air blow inconsistency.There is a 100 percent automated vision system inspection and a sampling plan implemented for tip spear which mitigates the occurrence of this defect.However, as the returned has been removed from the package and handled it is possible that the defects originated due to improper use either during tip adhesion break or during the venipuncture attempt in the clinician environment.A device history record review showed no non-conformances associated with this issue during the production of this batch.H3 other text : see h10.

• 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: 16427772
• MDR Text Key: 310145846
• Report Number: 1710034-2023-00126
• 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: 03/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 381423
• Device Catalogue Number: 381423
• Device Lot Number: 2229934
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/18/2022
• 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