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

Model Number 382533

Device Problem Device Markings/Labelling Problem (2911)

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

Event Date 12/16/2019

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 mixed product was found before use with a bd insyte¿ autoguard¿ bc shielded iv catheter.The following information was provided by the initial reporter, "i wanted to inform you that one of my asd nurses opened a 20 ga x 1.00 in auto guard angiocath?s with the reference number of 382533 and the lot# of 9289080.When they opened it, it did not have the safety cap with it and there is a 3 inch needle on it.I looked at all of the other ones we had with that lot and it looks like it was just the one.However, i feel i have to do my due diligence and make you aware.I do have the device in my possession along with the packaging.".

Event Description

It was reported that mixed product was found before use with a bd insyte¿ autoguard¿ bc shielded iv catheter.The following information was provided by the initial reporter: "i wanted to inform you that one of my asd nurses opened a 20 ga x 1.00 in auto guard angiocath?s with the reference number of 382533 and the lot# of 9289080.When they opened it, it did not have the safety cap with it and there is a 3 inch needle on it.I looked at all of the other ones we had with that lot and it looks like it was just the one.However, i feel i have to do my due diligence and make you aware.I do have the device in my possession along with the packaging.".

Manufacturer Narrative

H.6.Investigation: our quality engineer inspected the sample submitted for evaluation.Bd received one 20ga needle-barrel assembly within an open package from lot number 9289080.Through the examination, the needle was pushed into the out position where there was no visible damage observed.The reported issue of missing the needle cover was confirmed.Although the cover was missing, due to the sample being in an opened package we are unable to determine if the defect took place within the manufacturing process or in the user environment.Next, we reviewed the unit and measured the length of the needle.The needle measured within our specifications therefore we were unable to confirm the reported issue.A device history record review showed no non-conformances associated with this issue during the production of this batch.

• 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: 9563807
• MDR Text Key: 179337465
• Report Number: 1710034-2019-01395
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903825333
• UDI-Public: 30382903825333
• Combination Product (y/n): N
• PMA/PMN Number: K110443
• 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: 02/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 09/03/2022
• Device Model Number: 382533
• Device Catalogue Number: 382533
• Device Lot Number: 9289080
• Date Manufacturer Received: 12/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other