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

Model Number 382523

Device Problem Leak/Splash (1354)

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

Event Date 09/28/2021

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 the needle pierced through the bd insyte¿ autoguard¿ bc shielded iv catheter while introducing it into the patient's vein.The following information was provided by the initial reporter: "i talked to the nurse inserting the iv and she said: the catheter with needle did not look defective in any way out of the package.She entered the vein easily, and then started threading the catheter off of the needle.It would not thread and the needle was actually pushing itself back out of the patient.So she removed it, and the needle was coming out near the hub instead of at the tip ¿ where it should be.".

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 needle pierced through the bd insyte¿ autoguard¿ bc shielded iv catheter while introducing it into the patient's vein.The following information was provided by the initial reporter: "i talked to the nurse inserting the iv and she said: the catheter with needle did not look defective in any way out of the package.She entered the vein easily, and then started threading the catheter off of the needle.It would not thread and the needle was actually pushing itself back out of the patient.So she removed it, and the needle was coming out near the hub instead of at the tip ¿ where it should be.".

Event Description

It was reported that the needle pierced through the bd insyte¿ autoguard¿ bc shielded iv catheter while introducing it into the patient's vein.The following information was provided by the initial reporter: "i talked to the nurse inserting the iv and she said: the catheter with needle did not look defective in any way out of the package.She entered the vein easily, and then started threading the catheter off of the needle.It would not thread and the needle was actually pushing itself back out of the patient.So she removed it, and the needle was coming out near the hub instead of at the tip ¿ where it should be.".

Manufacturer Narrative

The following fields were updated due to additional information: device available for eval?: yes.Returned to manufacturer on: 12/9/2021.Investigation: the device displayed evidence of media found on it which therefore is unlikely that the spear through originated during the manufacturing process as the device would have been received with the needle piercing through the catheter tubing making a venipuncture attempt unlikely.A needle spear through may occur in the clinician setting during tip adhesion break or during venipuncture if the needle is advanced at a wrong angle or if the needle is moved up and down the catheter tubing.Based on the evidence, the spear through most likely originated during the venipuncture.A device history record review showed no non-conformances associated with this issue during the production of this batch.

• Brand Name: BD INSYTE¿ AUTOGUARD¿ BC 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 ; 8015296192
• MDR Report Key: 12985528
• MDR Text Key: 285954167
• Report Number: 1710034-2021-01045
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903825234
• UDI-Public: 30382903825234
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110443
• 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: 01/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 382523
• Device Catalogue Number: 382523
• Device Lot Number: 1123759
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/03/2021
• 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