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

Model Number 381812

Device Problem Material Puncture/Hole (1504)

Patient Problem Pain (1994)

Event Date 09/15/2021

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 bd insyte¿ autoguard¿ shielded iv catheter experienced a needle through the catheter.The following information was provided by the initial reporter: during the installation of a catheter on a newborn, the mandrel pierced the catheter, which damaged the venous capital and caused pain in the child.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 2021-10-08.H6: investigation summary our quality engineer inspected the sample and photograph submitted for evaluation.Bd received one unit without packaging and one photo.Microscopic inspection of the unit found that there was a v-shaped cut on the catheter tubing.This type of damage is indicative of a needle spear through, confirming the reported defect.Since it was indicated that the unit had been used, it is unlikely that the defect occurred during manufacturing 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 user setting during tip adhesion break, 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 event description and observations, it was determined that the defect likely occurred in the user environment.A device history record review showed no non-conformance's 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.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.

Event Description

It was reported that the bd insyte¿ autoguard¿ shielded iv catheter experienced a needle through the catheter.The following information was provided by the initial reporter: during the installation of a catheter on a newborn, the mandrel pierced the catheter, which damaged the venous capital and caused pain in the child.

• 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12648705
• MDR Text Key: 277252506
• Report Number: 1710034-2021-00889
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903818129
• UDI-Public: 00382903818129
• 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: 10/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 03/31/2023
• Device Model Number: 381812
• Device Catalogue Number: 381812
• Device Lot Number: 0093874
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/22/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/03/2020
• 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