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

Catalog Number 382534

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/04/2022

Event Type  Injury  

Manufacturer Narrative

Bd received three insyte autoguard blood control units for evaluation.One device was received inside its original packaging with the lot 1355856 clearly visible on the label.However, the other two devices were received outside of their original packaging with product label or lot details missing.This investigation will use the visible lot for its investigation.A review of the device history record was performed for the visible lot and no quality issues were found during production.Our quality engineer visually inspected each device and made the following observations.For the device received in its original packaging, no visible defects or damage was present.A water/air leak test was performed and no leaks were found.The device was determined to be functional and without defect.Next, the remaining two devices were inspected and it was found that one of the devices appeared to be used while the other wasn't.For the unused device, no visible damage or defects were observed.A water/air leak test was also performed for this unit and no leaks were found.This unit was determined to be functional and without defects.Finally, the device that appeared to be used was inspected.This unit was found to have a break in the catheter tubing and the missing portion of the tubing was not returned.This device was then investigated under a microscope.Three separate tears were found in the catheter tubing just below the catheter break.These three tears were small diagonal lines with a slight arc.The break itself was in the shape of a v that then transitioned to a flat break around the rest of the tubing.The surface of the break was mostly smooth where the v-shape was located and rough throughout the rest of the break.The presence of the v-shaped cut and the surface textures likely indicate that the catheter tubing was speared through by the needle and due to tensile stress over time, the rest of the catheter tubing was broken off.The smaller cuts are likely partial needle spear throughs.Given that the unit is used, it is likely that the needle spear throughs occurred during use.If the defect originated during the manufacturing process, the device would have been received by the end user with the needle piercing through the catheter tubing making a venipuncture attempt unlikely as the user would not be able to advance the catheter past the spear.Additionally, there are no know manufacturing related defects that would result in multiple catheter tears as seen on this unit.The manufacturing facility has been notified of this incident and the findings.

Event Description

It was reported that the catheter broke off inside the patient while using the bd insyte¿ autoguard¿ bc shielded iv catheter.There was no harm to the patient.The following information was provided by the initial reporter: customer reports the insyte autoguard catheter broke off inside the patient.

• 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: 14527480
• MDR Text Key: 293367450
• Report Number: 1710034-2022-00272
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903825349
• UDI-Public: 00382903825349
• 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
• Report Date: 05/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 382534
• Device Lot Number: 1355856
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/21/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention