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

Catalog Number 38101214

Device Problems Leak/Splash (1354); Misconnection (1399)

Patient Problem Skin Tears (2516)

Event Date 06/17/2023

Event Type  malfunction  

Manufacturer Narrative

H.3.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 difficult to connect to the neonatal extender during use, causing leakage.The following information was provided by the initial reporter, translated from portuguese: "peripheral venous catheter nº 24 with luer-lock connector with bad connection.Difficult to connect to the neonatal extender, causing leaks.Needle bevel not sharpy providing a traumatic venipunction to the tissues (sension of "tearing" the newborn's skin).".

Manufacturer Narrative

H6: investigation summary: there was no sample or photo 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 incident and the findings.A review of the device history record was performed and no quality issues were found during production.H3 other text : see h10.

Event Description

It was reported that the bd insyte¿ autoguard¿ bc shielded iv catheter was difficult to connect to the neonatal extender during use, causing leakage.The following information was provided by the initial reporter, translated from portuguese: "peripheral venous catheter nº 24 with luer-lock connector with bad connection.Difficult to connect to the neonatal extender, causing leaks.Needle bevel not sharpy providing a traumatic venipunction to the tissues (sension of "tearing" the newborn's skin).".

• 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: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17631751
• MDR Text Key: 322058127
• Report Number: 1710034-2023-00947
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K201075
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 38101214
• Device Lot Number: 3081895
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/08/2023
• Initial Date FDA Received: 08/28/2023
• Supplement Dates Manufacturer Received: 09/08/2023
• Supplement Dates FDA Received: 09/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/29/2023
• 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