MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD NEXIVA¿ CLOSED IV CATHETER SYSTEM; INTRAVASCULAR CATHETER

Model Number	383538
Medical Device Problem Codes	Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that during use, the bd nexiva¿ closed iv catheter system produced a "pop" where the needle pushed back into the catheter lumen, and failed to puncture the patient's skin.The following information was provided by the initial reporter: "i myself, and fellow coworkers began experiencing issues with these ivs on friday.Though i have not ever experienced this issue before, when attempting to stick a patient, there is like a pop where the needle pushes back inside the catheter lumen; consequently, we are left wondering "why isn't this puncturing the skin." it is almost like the needle is dull.".
Event or Problem Description
It was reported that during use, the bd nexiva¿ closed iv catheter system produced a "pop" where the needle pushed back into the catheter lumen, and failed to puncture the patient's skin.The following information was provided by the initial reporter: "i myself, and fellow coworkers began experiencing issues with these ivs on friday.Though i have not ever experienced this issue before, when attempting to stick a patient, there is like a pop where the needle pushes back inside the catheter lumen; consequently, we are left wondering "why isn't this puncturing the skin." it is almost like the needle is dull.".
Additional Manufacturer Narrative
The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 2/17/2020.H.6.Investigation: our quality engineer inspected the samples and photographs submitted for evaluation.Bd received a total of 68 unused representative 20ga bd nexiva closed iv catheter system ¿dual port units within undamaged sealed packages from lot number 9325212, reference number 383538.All components were present and intact.A penetration and drag test was performed on the units.55 of the 68 units failed the test for needle tip penetration force.The reported issue was confirmed.The dhr for lot number 9325212 has been reviewed.Qn (b)(4) (suspect penetration and drag oos) was initiated and could potentially be related to this incident.This was physical/mechanical evidence to confirm and support a manufacturing related issue for the reported defect relating to either the manufacturing process or raw material received.Damaged cannulas can occur during multiple stages of manufacturing such as improper angle of release at offload, operator handling, and/or gripper damage.Capa#708490 was initiated.This capa has introduced a new tamping tool to reduce the likely hood of operator handling affecting the cannula tip quality.The tamping tool is used to move the cannulas flush in the hopper, so they can feed into the manufacturing equipment.

• Brand Name: BD NEXIVA¿ CLOSED IV CATHETER SYSTEM
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 9716887
• Report Number: 1710034-2020-00082
• Device Sequence Number: 3159625
• Product Code: FOZ
• UDI-Device Identifier: 30382903835387
• UDI-Public: 30382903835387
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K183399
• 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,Followup
• Report Date (Section B): 04/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 10/31/2022
• Device Model Number: 383538
• Device Catalogue Number: 383538
• Device Lot Number: 9325212
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2020
• Initial Date Received by Manufacturer: 01/26/2020
• Supplement Date Received by Manufacturer: 01/26/2020
• Initial Report FDA Received Date: 02/17/2020
• Supplement Report FDA Received Date: 04/21/2020
• 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