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

Catalog Number 383536

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 06/04/2018

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 blood was not fully clearing from a bd nexiva¿ closed iv catheter system w/ dual port extension sets once flushed.There was no report of exposure, injury, or medical intervention.

Event Description

It was reported that blood was not fully clearing from a bd nexiva¿ closed iv catheter system w/ dual port extension sets once flushed.There was no report of exposure, injury, or medical intervention.

Manufacturer Narrative

Investigation summary: received a 20ga nexiva catheter-adapter extension set dual port unit wrapped on surgical tape along with a piece of top web (packaging) from lot number 7349564.The needle-tip shield assembly and needle cover were not received for evaluation.The unit revealed traces of blood and the pinch clamp was fully engaged.Dhr review: the lot was manufactured on nfa line 1 from 20dec17 through 2jan18.A non-related qn (200725749) for incomplete seal was initiated-quality plan was followed.All other challenge, set-up and in process samples were performed per quality plan and all passed per specifications.Visual/microscopic examination: no physical-mechanical damage was observed on any of the components of the unit received.No holes, bends, splints, kinks or wrinkles were observed on catheter tubing the extension tubing was not cut or damaged water-leak test: no leakage was observed on any of the areas of the unit received.Fluid-flush test: using a lab provided syringe filled with water-food coloring solution flushed the liquid through the unit (pinch clamp not engaged).Flush was successful, no obstruction was observed.Then, engaged the pinch clamp and attempted to push the liquid through, the liquid did not flow, the pinch clamp performed as intended.Conclusion(s):flashback test was successful, the cannula revealed damage on its tip (blunt) eura (end user risk analysis) findings: the failure mode and cause of failure could not be determined as the returned unit did not display any adverse characteristics that would contribute to the defect as described by the customer.Rm5769 rev 14(m) nexiva a-eura has identified inadequate flush of the device as a failure mode and assessed the current risk to the end user as acceptable.Rm5619 rev 17(o) nexiva d-eura has identified blood reflux back into the device due to inadequate engagement of the pinch clamp as a failure mode and assessed the current risk to the end user as acceptable.Root cause for this incident is indeterminate.The returned unit did not display any adverse characteristics that would contribute to the defect the customer experienced.The defect described in the incident report could not be confirmed or replicated.A formal corrective action will not be initiated at this time.Customer complaint trends are evaluated on a quarterly basis.If the trend of a specific type of complaint warrants a formal corrective action, resources will be assigned at that time.

• Brand Name: BD NEXIVA¿ CLOSED IV CATHETER SYSTEM W/ DUAL PORT
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 7636556
• MDR Text Key: 112436574
• Report Number: 1710034-2018-00392
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903835363
• UDI-Public: 30382903835363
• Combination Product (y/n): N
• PMA/PMN Number: K161777
• 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: 09/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 11/30/2020
• Device Catalogue Number: 383536
• Device Lot Number: 7349564
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2018
• Date Manufacturer Received: 06/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other