MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. INSYTE AUTOG BC YEL 24GA X 0.75IN; INTRAVASCULAR CATHETER

Model Number 382512

Device Problems Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Patient Involvement (2645)

Event Date 08/12/2020

Event Type  malfunction  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).

Event Description

It was reported that a insyte autog bc yel 24ga x 0.75in had the catheter split during use.The following was reported by the initial reporter: "it was reported that the plastic catheter covering the needle was ripped on the tip.Verbatim: rn was trying to start an iv on the patient (using a 24 ga x 0,75 in bd insyte autoguard bc iv) she was unsuccessful when she pulled out the needle and catheter.She saw that the plastic catheter covering the needle was ripped on the tip.It was all there just ripped.The needle and packaging were put in a biohazard bad and given to manager.".

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.The complaint could not be confirmed and the root cause was not determined.

Event Description

It was reported that a insyte autog bc yel 24ga x 0.75in had the catheter split during use.The following was reported by the initial reporter: "it was reported that the plastic catheter covering the needle was ripped on the tip.Verbatim: rn was tryingto start an iv on the patient(using a 24 ga x 0,75 in bd insyte autoguard bc iv) she was ununsuccessful when she pulled out the needle and catheter.She saw that the plastic catheter covering the needle was ripped on the tip.It was all there just ripped.The needle and packaging were put in a biohazard bad and goiven to manager.".

• Brand Name: INSYTE AUTOG BC YEL 24GA X 0.75IN
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 10787196
• MDR Text Key: 219382377
• Report Number: 1710034-2020-00704
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903825128
• UDI-Public: 30382903825128
• Combination Product (y/n): N
• PMA/PMN Number: K110443
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 12/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 03/31/2022
• Device Model Number: 382512
• Device Catalogue Number: 382512
• Device Lot Number: 9101767
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1