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

Model Number 381423

Device Problems Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)

Patient Problems Fever (1858); Vomiting (2144)

Event Date 10/21/2020

Event Type  Injury  

Manufacturer Narrative

A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).

Event Description

It was reported that the bd insyte¿ autoguard¿ shielded iv catheter caused the patient's vein to blow, and would not come out until vat was called to remove it.Upon removal, a "slit/puncture" was found in the catheter, and the patient required additional needle procedure for another iv placement.The following information was provided by the initial reporter: "rn went to place iv in patient's left ac, retracted needle and obtained cultures.Vein blew and when this rn went to remove iv catheter, it would not come out.This rn never rethreaded needle into the catheter.Vat called to bedside and removed catheter from patient.When catheter was removed, it has a slit/puncture in it.Catheter and packaging was bagged.Patient and family updated through entire process." "yes, patient required additional needle procedure for iv placement" "causing fever and vomiting.".

Manufacturer Narrative

H6: investigation summary our quality engineer inspected the sample submitted for evaluation.Bd received a catheter adapter assembly attached to miscellaneous tubing.Before decontamination, media was present throughout the catheter and extension tubing indicating that venipuncture did occur.Through the microscopic examination the unit revealed skiving and a v-shaped hole near the tip of the catheter which indicates that the cannula tip had scratched and pierced the catheter wall confirming damage to the catheter.This defect can occur during the manufacturing process or during use of the product.Typically, if this occurs during the manufacturing process a more well defined v-shaped cut is present and would be very noticeable upon unpacking in the user environment.Then if venipuncture was attempted, it would be very problematic.Based on the evidence and report that venipuncture did occur, the more likely cause is the catheter damage occurred during use.This can occur if the cannula is moved up and down within the catheter tubing while attempting venipuncture.A device history record review showed no non-conformances associated with this issue during the production of this batch.See h.10.

Event Description

It was reported that the bd insyte¿ autoguard¿ shielded iv catheter caused the patient's vein to blow and would not come out until vat was called to remove it.Upon removal, a "slit/puncture" was found in the catheter, and the patient required additional needle procedure for another iv placement.The following information was provided by the initial reporter: "rn went to place iv in patient's left ac, retracted needle and obtained cultures.Vein blew and when this rn went to remove iv catheter, it would not come out.This rn never rethreaded needle into the catheter.Vat called to bedside and removed catheter from patient.When catheter was removed, it has a slit/puncture in it.Catheter and packaging was bagged.Patient and family updated through entire process." "yes, patient required additional needle procedure for iv placement" "causing fever and vomiting.".

• 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: 10841530
• MDR Text Key: 216313415
• Report Number: 1710034-2020-00728
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903814238
• UDI-Public: 30382903814238
• Combination Product (y/n): N
• PMA/PMN Number: K952861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 12/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2023
• Device Model Number: 381423
• Device Catalogue Number: 381423
• Device Lot Number: 0164707
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2020
• Initial Date Manufacturer Received: 10/21/2020
• Initial Date FDA Received: 11/15/2020
• Supplement Dates Manufacturer Received: 12/09/2020
• Supplement Dates FDA Received: 12/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 7 YR