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

Model Number 381812

Device Problem Material Puncture/Hole (1504)

Patient Problem Bruise/Contusion (1754)

Event Date 06/21/2022

Event Type  malfunction  

Event Description

It was reported that while using a bd insyte¿ autoguard¿ shielded iv catheter the needle punctures through the plastic iv cannula.The following information was provided by the initial reporter: the issue is that the needle punctures through the plastic iv cannula while it is inserted in the patient's vein.Mechanically, i'm not quite sure how this happens, but it has resulted in multiple pokes for our iv patients and leaving some trauma/bruising beneath the skin.

Manufacturer Narrative

The date received by manufacturer has been used for date of event.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Manufacturer Narrative

Investigation summary: 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.

Event Description

It was reported that while using a bd insyte¿ autoguard¿ shielded iv catheter the needle punctures through the plastic iv cannula.The following information was provided by the initial reporter: the issue is that the needle punctures through the plastic iv cannula while it is inserted in the patient's vein.Mechanically, i'm not quite sure how this happens, but it has resulted in multiple pokes for our iv patients and leaving some trauma/bruising beneath the skin.

• Brand Name: BD INSYTE¿ 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
• Manufacturer (Section G): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15080550
• MDR Text Key: 304796577
• Report Number: 1710034-2022-00376
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903818129
• UDI-Public: 00382903818129
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K201075
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 08/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2024
• Device Model Number: 381812
• Device Catalogue Number: 381812
• Device Lot Number: 1267811
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/21/2022
• Initial Date FDA Received: 07/21/2022
• Supplement Dates Manufacturer Received: 08/26/2022
• Supplement Dates FDA Received: 09/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/24/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1