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

Catalog Number 381044

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

Patient Problems Pain (1994); Phlebitis (2004)

Event Date 09/18/2019

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.

Event Description

It was reported that the bd insyte¿ autoguard¿ bc shielded iv catheter was used on a patient with vaginal bleeding, and pain and "sensation of mass" occurred in the left wrist after use.An ultrasound of the soft tissue was performed, and "linear intraluminal imaging with double echogenic line" was evident at the level of the "metacarpal vein".This reportedly limited the vessel boundary, which measured "15 mm".Exploratory vessel surgery was undergone on september 19th to remove the vialon piece from the vessel, but the surgeon reported finding "nothing" but phlebitis in the area.The following information was provided by the initial reporter, translated from spanish to english: "patient was hospitalized the previous week and channeled with insyte, who is admitted today to the emergency room due to pain in her left hand.Vialon within the vein is visualized on the ultrasound image.6 days ago, appointment for vaginal bleeding, it was performed canalization in the peripheral vein.After that, there was pain and sensation of mass in the left wrist.Ultrasound of soft tissues is performed with the following report: at the level of the left hand metacarpal vein, echogenic linear intraluminal imaging with double echogenic line is evident, which limits vessel boundary that measures 15 mm." (19.Sep) in the morning, the patient enters the operating room, the surgeon reports that he finds nothing, that it was a phlebitis.According to the sales rep, due to the suspicion that the catheter had remained in the patient's hand, an exploratory vessel surgery was necessary, but the hospital suspects that the medication applied may have contributed to the incident.Customer also reported patient data.

Manufacturer Narrative

H.6.Investigation summary: there were no samples or photos available to bd for evaluation.Therefore, bd was unable to perform a thorough investigation to verify the reported issue.Since, an investigation could not be performed bd was unable to determine a possible root cause.The manufacturing facility has been notified of this event but without a sample no corrective actions could be identified.A review of the device history record was performed and no quality issues were found during production.H3 other text : see section h.10.

Event Description

It was reported that the bd insyte¿ autoguard¿ bc shielded iv catheter was used on a patient with vaginal bleeding, and pain and "sensation of mass" occurred in the left wrist after use.An ultrasound of the soft tissue was performed, and "linear intraluminal imaging with double echogenic line" was evident at the level of the "metacarpal vein".This reportedly limited the vessel boundary, which measured "15 mm".Exploratory vessel surgery was undergone on (b)(6) to remove the vialon piece from the vessel, but the surgeon reported finding "nothing" but phlebitis in the area.

• 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
• MDR Report Key: 9151542
• MDR Text Key: 167659374
• Report Number: 1710034-2019-01076
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: K110443
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 10/29/2019

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: Other
• Device Expiration Date: 10/31/2021
• Device Catalogue Number: 381044
• Device Lot Number: 8304587
• Initial Date Manufacturer Received: 09/18/2019
• Initial Date FDA Received: 10/03/2019
• Supplement Dates Manufacturer Received: 09/18/2019
• Supplement Dates FDA Received: 10/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 18 YR