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

Catalog Number 381511

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/27/2023

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 with 2 bd insyte¿-n autoguard¿ shielded iv catheter the catheter sheared.Patient had to be stuck several times due to the shearing.The following information was provided by the initial reporter: (1st of 2 occurrences) one of our nicu baby¿s needed an iv.Two nurses were working together to place it.They used this product and the catheter sheared when she tried to put it in.This actually happened three time with the same lot number on three different catheters.I do not think the nurse thought to look at the lot until after the fact but it was all the same lot number: 2146599.

Manufacturer Narrative

H.6.Investigation summary: since no samples displaying the condition reported were available for examination, we were unable to fully investigate this incident.Examination of the actual product involved may provide clarification as to the cause for the reported failure.A device history record review showed no non-conformances associated with this issue during the production of this batch.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.H3 other text : see h10.

Event Description

It was reported that during use with 2 bd insyte¿-n autoguard¿ shielded iv catheter the catheter sheared.Patient had to be stuck several times due to the shearing.The following information was provided by the initial reporter: (1st of 2 occurrences).One of our nicu baby¿s needed an iv.Two nurses were working together to place it.They used this product and the catheter sheared when she tried to put it in.This actually happened three time with the same lot number on three different catheters.I do not think the nurse thought to look at the lot until after the fact but it was all the same lot number, 2146599.

• Brand Name: BD INSYTE¿-N 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
• 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 ; 8448235433
• MDR Report Key: 16448859
• MDR Text Key: 310341174
• Report Number: 1710034-2023-00149
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903815111
• UDI-Public: 00382903815111
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K952861
• 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,Followup
• Report Date: 04/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 381511
• Device Lot Number: 2146599
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/03/2022
• 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