MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE AUTOGUARD SHIELDED IV CATHETER 20GA 1.88IN (1.1 X 48 MM); INTRAVASCULAR CATHETER

Model Number	381437
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/16/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Investigation summary: dhr for lot 0021768 has been reviewed.This lot number was built on afa line 6 from 30jan2020 through 03feb2020 and packaged on pkg.Line 11 from 04feb through 13mar2020 for the quantity of 262,0110 units.No related quality or process deviations were found.Peura (b)(4), version q has been reviewed.This type of failure has been included and assessed for risk on multiple pages, and it is impossible to narrow it down without the sample.Investigation conclusion: customer complaint trends are evaluated on a monthly basis, however the need for a formal corrective action cannot be determined in the absence of the root cause.Risk to the end user is established based on occurrence and severity of the defect as related to a specific failure mode in the manufacturing process and the effects of that failure.The risk could not be evaluated for the unconfirmed defect in the absence of the root cause.
Event or Problem Description
It was reported that the bd insyte¿ autoguard¿ shielded iv catheter 20ga 1.88in (1.1 x 48 mm) experienced leakage at the catheter and hub junction during use.The following information was provided by the initial reporter: today attempted to place a 2nd iv in a patient with u/s and draw the 2nd set of cultures and got good blood return but noted that there bubbles noted in end of catheter while drawing blood.I sent off the cultures and upon flushing the iv 1.88""it was noted that there was a leak where the pink part of the angiocath and the catheter meet.I pulled the iv and there was not infiltration because the part that was leaking was on the outside of the skin.The iv in question is a bd insyte autoguard 20ga x 1.88 in.Ref 381437, 00382903814374, lot 0021768, exp 2022-12-31.

• Brand Name: BD INSYTE AUTOGUARD SHIELDED IV CATHETER 20GA 1.88IN (1.1 X 48 MM)
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 10659912
• Report Number: 1710034-2020-00658
• Device Sequence Number: 3281293
• Product Code: FOZ
• UDI-Device Identifier: 30382903814375
• UDI-Public: 30382903814375
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K952861
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/25/2020

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
• Operator of Device: Other
• Device Expiration Date: 12/31/2022
• Device Model Number: 381437
• Device Catalogue Number: 381437
• Device Lot Number: 0021768
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/17/2020
• Initial Report FDA Received Date: 10/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other