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

Model Number 382523

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Thrombus (2101)

Event Date 01/14/2020

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.Device manufacture date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that the bd insyte¿ autoguard¿ bc shielded iv catheter blood control technology 20ga 1.00in during use cause blood clots.The following information was provided by the initial reporter: material no.: 382523, batch no.: unknown.Verbatim: ¿it was reported that a mckesson rep called and left a voicemail stating that the autoguard catheter # 382523 has caused blood clots on 2 different patients.".

Event Description

It was reported that the bd insyte¿ autoguard¿ bc shielded iv catheter blood control technology 20ga 1.00in during use cause blood clots.The following information was provided by the initial reporter: material no.: 382523; batch no.: unknown.Verbatim: ¿it was reported that that a mckesson rep called and lefft a voicemail stating that the autoguard catheter # 382523 has caused blood clots on 2 different patients.".

Manufacturer Narrative

H.6.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.Complaint could not be confirmed and root cause is undetermined.H3 other text : see h.10.

• 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: 9666868
• MDR Text Key: 188325091
• Report Number: 1710034-2020-00049
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903825234
• UDI-Public: 30382903825234
• Combination Product (y/n): N
• PMA/PMN Number: K110443
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Type of Report: Initial,Followup
• Report Date: 02/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 382523
• Device Catalogue Number: 382533
• Device Lot Number: 8262697
• Date Manufacturer Received: 01/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other