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

Catalog Number 383539

Device Problem Fail-Safe Design Failure (1222)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/31/2018

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that when the nurse pulled the needle out of the placed plastic bd nexiva¿ closed iv catheter system, the "guard" covering the needle fell apart and the end of the needle was exposed.The nurse noticed the pin that holds the shield, and the needle fell out twice.No reports of serious injury or medical intervention noted.

Event Description

It was reported that when the nurse pulled the needle out of the placed plastic bd nexiva closed iv catheter system, the "guard" covering the needle fell apart and the end of the needle was exposed.The nurse noticed the pin that holds the shield, and the needle fell out twice.No reports of serious injury or medical intervention noted.

Manufacturer Narrative

Received a total of 3 catheter-adapter-ex.Sets, 3 needle covers, 2 q-syte units, 1 tip shield, 1 tip shield-grip assembly, 1 washer in a bag with handwritten notes, 1 cannula + a tip shield and a grip in a bag with a handwritten note and 3 empty-open packages from lot number 8087800 dhr review shows the lot was manufactured on nexiva line 1 from (b)(6) 2018 through (b)(6) 2018.All challenges were successful.Set-up and in process samples including (but not limited to) machine caused damaged were performed at various stages during the manufacturing process and all passed per specification.Visual/microscopic evaluation: observed the cannula returned for evaluation had a bump according to specification.Observed the tip shields were missing the washers.No further observations could be performed since the condition of the other cannulas is unknown.The failure experienced by the customer was confirmed, the grip-shield assemblies separated from the cannulas and the washers were missing.Bd was unable to reproduce the customer¿s experience in the laboratory environment.This incident is currently being investigated through a voluntary recall including field action: (b)(4).This is an issue with the safety feature of the device.Although occurrence is low and all reported incidents thus far have limited severity (contaminated needle stick injury with no known blood borne pathogen), there is the potential for higher severity end user effects.A capa project has been opened to address this incident.(b)(4) problem statement: the tip shield did not properly capture the tip of some nexiva 18ga needle between the v-clip and washer.Instead, due to the failure mode of bump out of specification (small or missing), the needle pulled through the washer and allowed the gray tip shield to disconnect from the needle assembly.

• Brand Name: BD NEXIVA¿ CLOSED IV CATHETER SYSTEM
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 7621597
• MDR Text Key: 112046631
• Report Number: 1710034-2018-00372
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903835394
• UDI-Public: 30382903835394
• Combination Product (y/n): N
• PMA/PMN Number: K111366
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 09/25/2018

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
• Device Operator: Nurse
• Device Expiration Date: 02/28/2018
• Device Catalogue Number: 383539
• Device Lot Number: 8087800
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2018
• Initial Date Manufacturer Received: 05/31/2018
• Initial Date FDA Received: 06/20/2018
• Supplement Dates Manufacturer Received: 05/31/2018
• Supplement Dates FDA Received: 09/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other