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

Catalog Number 381934

Device Problems Entrapment of Device (1212); Improper or Incorrect Procedure or Method (2017); Migration (4003)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/06/2019

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 during use of the bd insyte¿ autoguard¿ shielded iv catheter the operator cannulated a patient's peripheral vein, but the catheter migrated into the patient's vein.The operator reports that there were no wing (and needle hub?) in the package or the work table.As a consequence there stays that the surgical intervention was needed.The following information was provided by the initial reporter: the operator cannulated a patient's peripheral vein, but the catheter migrated into the patient's vein.The operator reports that there were no wing (and needle hub?) in the package or the work table.As a consequence there stays that the surgical intervention was needed.The user notified the event to the authorities.The customer reports no issue with other devices from the sample lot.Please note i received the fax and i need to come back to the customer.If the hub and wings are missing the device shouldn't be used.From the description i see the catheter was "lost" in the vein and the consequence was the surgical intervention.Information received on 03/15: our sales rep.Met the customer: here below what he reported.What is happened is not clear: the catheter seems to have detached from the hub and it does not seem to be cut.The hcp realized it when he activated the safety mechanism.The activation cause the detachment of the hub leaving the catheter in vein with blood leakage.They did acupressure to stop the blood leakage: the catheter has been inadvertently pushed in the vein and they were not able to get it out.They use ultrasound to confirm the presence of the catheter in the vein.3 hcps and the patient confirmed this description.

Event Description

It was reported that during use of the bd insyte¿ autoguard¿ shielded iv catheter the operator cannulated a patient's peripheral vein, but the catheter migrated into the patient's vein.The operator reports that there were no wing (and needle hub?) in the package or the work table.As a consequence there stays that the surgical intervention was needed.The following information was provided by the initial reporter: the operator cannulated a patient's peripheral vein, but the catheter migrated into the patient's vein.The operator reports that there were no wing (and needle hub?) in the package or the work table.As a consequence there stays that the surgical intervention was needed.The user notified the event to the authorities.The customer reports no issue with other devices from the sample lot.Please note i received the fax and i need to come back to the customer.If the hub and wings are missing the device shouldn't be used.From the description i see the catheter was "lost" in the vein and the consequence was the surgical intervention.Information received on 03/15: our sales rep.Met the customer: here below what he reported.What is happened is not clear: the catheter seems to have detached from the hub and it does not seem to be cut.The hcp realized it when he activated the safety mechanism.The activation cause the detachment of the hub leaving the catheter in vein with blood leakage.They did acupressure to stop the blood leakage: the catheter has been inadvertently pushed in the vein and they were not able to get it out.They use ultrasound to confirm the presence of the catheter in the vein.3 hcps and the patient confirmed this description.

Manufacturer Narrative

Investigation: during dhr review all required challenge samples, set-up and testing was conducted per specifications and in accordance with the in-process sampling plans.There were no indications of reject activity throughout the build of this lot that would impact the outcome of the quality of the product relevant to the reported defects.The reported defects were not identified or confirmed and a definite root cause could not be established as no units were provided for this incident.Without the actual sample(s) for evaluation and testing there was no physical/mechanical evidence to confirm or support manufacturing process related issues that would contribute to the alleged defects.

• 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
• MDR Report Key: 8465571
• MDR Text Key: 140353247
• Report Number: 1710034-2019-00348
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: K952861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 04/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 03/31/2021
• Device Catalogue Number: 381934
• Device Lot Number: 8093650
• Date Manufacturer Received: 03/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention