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

Catalog Number 381411

Device Problems Product Quality Problem (1506); Suction Problem (2170)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/15/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that bd insyte-n¿ autoguard¿ shielded iv catheter did not get a flash back like they used to.The following information was provided by the initial reporter: material no.381411, batch no.Unknown.It was reported there is an issue with the 24 ga insyte catheter.I am contacting you about a problem that the special care nursery is having with the 24 ga insyte catheter #381411.The manager of the area said that she noticed a change in packaging and since that occurred they are having problems with the product.The package changed with the 24 g insytes, since then the staff have noticed that when they use them they don¿t get a flash back like they used to.Unfortunately this has happened with multiple patients and multiple staff before they realized it could be a product issue.Three specific patients had more than 7 attempts and on two patients central lines were placed because they could not obtain iv access with these newborns in our special care.

Event Description

It was reported that bd insyte-n¿ autoguard¿ shielded iv catheter did not get a flash back like they used to.The following information was provided by the initial reporter: material no.381411 batch no.Unknown it was reported there is an issue with the 24 ga insyte catheter.I am contacting you about a problem that the special care nursery is having with the 24 ga insyte catheter #381411.The manager of the area said that she noticed a change in packaging and since that occurred they are having problems with the product.The package changed with the 24 g insytes, since then the staff have noticed that when they use them they don¿t get a flash back like they used to.Unfortunately this has happened with multiple patients and multiple staff before they realized it could be a product issue.Three specific patients had more than 7 attempts and on two patients central lines were placed because they could not obtain iv access with these newborns in our special care.

Manufacturer Narrative

Bd was not able to duplicate or confirm the customer¿s indicated failure as no sample, batch, or lot code was provided.Dhr could not be performed.Root cause could not be determined.

• 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: 8654818
• MDR Text Key: 146624929
• Report Number: 1710034-2019-00561
• 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: 06/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 381411
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention