MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. INSYTE AUTOGUARD BC WINGED SHIELDED IV CATHETER BLOOD CONTROL TECHNOLOGY; INTRAVASCULAR CATHETER

Model Number 382633

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Patient Involvement (2645)

Event Date 07/09/2020

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.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 20 bd insyte¿ autoguard¿ bc winged shielded iv catheters blood control technology were incorrectly colored.The following information was provided by the initial reporter: "it was reported that jelcos should be pink, but are very pale or clear in color.Issue: today i was brought about 20 more jelcos that should be pink that are very pale or clear in color.".

Event Description

It was reported that 20 bd insyte¿ autoguard¿ bc winged shielded iv catheters blood control technology were incorrectly colored.The following information was provided by the initial reporter: "it was reported that jelcos should be pink, but are very pale or clear in color.Issue: today i was brought about 20 more jelcos that should be pink that are very pale or clear in color.".

Manufacturer Narrative

The following additional information was received: additional lot #: d.4.Medical device lot #: 0090867.D.4.Medical device expiration date: 2023-03-31.H.4.Device manufacture date: 2020-03-30.

Event Description

It was reported that 20 bd insyte¿ autoguard¿ bc winged shielded iv catheters blood control technology were incorrectly colored.The following information was provided by the initial reporter: "it was reported that jelcos should be pink, but are very pale or clear in color.Issue: today i was brought about 20 more jelcos that should be pink that are very pale or clear in color.".

Manufacturer Narrative

The following fields were updated due to additional information: d.10 device available for eval yes.D.10 returned to manufacturer on: 2020-07-27.H.6.Investigation summary our quality engineer inspected the samples submitted for evaluation.Bd received thirteen unused iag bc 20ga units in sealed packages from material number 382633, lot number 0111292 and one unused iag bc 20ga unit in a sealed package from material number 382633, lot number 0090867.A visual / microscopic evaluation was performed on the fourteen returned units.It was observed that color of the adapters ranged from almost colorless to light pink.Further analysis was conducted by comparing the luer end of each part to a color chip to assure color was within nominal range.All fourteen units failed the specification, confirming the reported issue.Before startup of the manufacturing process, the color feeder is cleared and the new color is added.Due to the no color/slight color of the units, the most probable cause is an error during the color change over process.A device history record review showed no non-conformance's associated with this issue during the production of this batch.

• Brand Name: INSYTE AUTOGUARD BC WINGED SHIELDED IV CATHETER BLOOD CONTROL TECHNOLOGY
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 10359596
• MDR Text Key: 202772743
• Report Number: 1710034-2020-00490
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903826330
• UDI-Public: 30382903826330
• 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,Followup
• Report Date: 09/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 03/31/2023
• Device Model Number: 382633
• Device Catalogue Number: 382633
• Device Lot Number: 0111292
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2020
• Date Manufacturer Received: 07/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other