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

Catalog Number 382644

Device Problem Defective Device (2588)

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

Event Date 03/22/2019

Event Type  malfunction  

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 a bd insyte¿ autoguard¿ bc shielded iv catheter was defective.The following was reported, "both iv's seem to be shriveled, cut or uneven at the end of the catheter tip.There were two actual ivs involved from two different clinicians, both had the same problem and situation.Please let me know if you need more info.".

Event Description

It was reported that a bd insyte¿ autoguard¿ bc shielded iv catheter was defective.The following was reported, "both iv's seem to be shriveled, cut or uneven at the end of the catheter tip.There were two actual ivs involved from two different clinicians, both had the same problem and situation.Please let me know if you need more info.".

Manufacturer Narrative

Investigation: since no samples displaying the condition reported were available for examination, we were unable to fully investigate this incident.A device history record review showed no non-conformances associated with this issue during the production of this batch.The complaint could not be confirmed and a root cause not determined.

• 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: 8499930
• MDR Text Key: 141579988
• Report Number: 1710034-2019-00398
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903826446
• UDI-Public: 30382903826446
• 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: 06/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 10/31/2021
• Device Catalogue Number: 382644
• Device Lot Number: 8310619
• Date Manufacturer Received: 03/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other