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

Catalog Number 381411

Device Problem Material Integrity Problem (2978)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 06/11/2019

Event Type  Injury  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.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 user could not start the bd insyte-n¿ autoguard¿ shielded iv catheter on a neonatal patient in the nicu, going through multiple sticking attempts before deciding to insert a uvc instead.This complaint was created to capture the 1st of 2 related incidents.The following information was provided by the initial reporter: "we are quite frustrated with the bd insyte-n angiocatheters.In the last 6 months, we have seen an increase in the number of attempts it is taking us to start ivs on our neonates.This past week, we had one infant who took 14 sticks before they gave up and put in a uvc, and another infant who went through 24 sticks.".

Manufacturer Narrative

Investigation: 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.A review of the device history record was performed and no quality issues were found during production.

Event Description

It was reported that the user could not start the bd insyte-n¿ autoguard¿ shielded iv catheter on a neonatal patient in the nicu, going through multiple sticking attempts before deciding to insert a uvc instead.This complaint was created to capture the 1st of 2 related incidents.The following information was provided by the initial reporter: "we are quite frustrated with the bd insyte-n angiocatheters.In the last 6 months, we have seen an increase in the number of attempts it is taking us to start ivs on our neonates.This past week, we had one infant who took 14 sticks before they gave up and put in a uvc, and another infant who went through 24 sticks.".

• 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
• MDR Report Key: 8735140
• MDR Text Key: 149238488
• Report Number: 1710034-2019-00676
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903814115
• UDI-Public: 30382903814115
• 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: 07/18/2019

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: 12/31/2021
• Device Catalogue Number: 381411
• Device Lot Number: 9024526
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/11/2019
• Initial Date FDA Received: 06/26/2019
• Supplement Dates Manufacturer Received: 06/11/2019
• Supplement Dates FDA Received: 07/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention