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

Catalog Number 383531

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Loss of consciousness (2418)

Event Date 07/23/2018

Event Type  Injury  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that an oncology patient had a bd nexiva¿ closed iv catheter system placed to receive hydration.After beginning the hydration treatment, the patient was found ¿unresponsive¿ (¿there was no code but the patient did not rouse to touch or stimuli ¿ similar to a coma state.  the patient did not faint").The patient was taken to the emergency department where ¿original pump tubing; iv catheter were discarded.¿ no additional treatment was reported.

Event Description

It was reported that an oncology patient had a bd nexiva¿ closed iv catheter system placed to receive hydration.After beginning the hydration treatment, the patient was found ¿unresponsive¿ (¿there was no code, but the patient did not rouse to touch or stimuli ¿ similar to a coma state.  the patient did not faint").The patient was taken to the emergency department where ¿original pump tubing & iv catheter were discarded.¿ no additional treatment was reported.

Manufacturer Narrative

Due to an it issue beginning on (b)(6) 2018, previously filed emdrs did not contain required fields.This supplemental emdr is filed to provide the following omitted fields: event attributed to: required invervention.Device single use?: no.Device returned to manufacture: yes.Investigation summary: received three unused represent neiva 24ga units in sealed packages.A complaint history check was performed and this is the 1st related complaint reported with the defect/condition of reaction (allergic/etc.) with lot #: 8047612 regarding item #: 383531.No trends related to this defect were identified by the qda.Dhr review was performed on lot number: 8047612; the lot number was built/packaged on nfa line 2 from december 7, 2017 thru december 10, 2017.Review of dhr revealed all required challenge samples and testing was conducted per specifications and in accordance with the in-process sampling plans.Review disclosed there were four non-related qn¿s initiated would not impact the outcome of the quality of the product relevant to the defect stated in the pir.The cause of failure and failure mode could not be determined as representative samples received did not display the defect reported.Rm5796 rev 16(o) nexiva p-eura identifies the potential failure modes and causes of failure that would result in an end user effect of leakage.Risk to the end user has been deemed acceptable due to the severity and occurrence of a particular leakage effect being low, or because the risk has been mitigated as much as possible and the benefit to the end user outweighs the risk.Water-leak test: the water leak test was performed on the packages.There were no leaks or opened seals.Visual/microscopic evaluation: the needle was not crimped, curved or bent.No holes, kinks, splits, or wrinkles were found in the tubing.Lie distance was within the acceptable range of.001 - 0.032 inches.Cannula tip quality was acceptable.Catheter tips were graded a 4, acceptable.The biological indicator test reports were reviewed, passed.The pyrogen samples also passed all testing.Root cause was indeterminate.No physical evidence to confirm or to support manufacturing process related issues for the defect.The returned units did not display any adverse characteristics that would contribute to the defect the customer complained about.The defect described in the incident report could not be confirmed or replicated with the returned units.The actual defective unit was not returned for evaluation and testing.A formal corrective action will not be initiated at this time.A manufacturing related root cause could not be identified.Customer complaint trends are evaluated on a monthly 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
• Type of Device: IV CATHETER SYSTEM
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 7757491
• MDR Text Key: 116254598
• Report Number: 1710034-2018-00530
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903835317
• UDI-Public: 00382903835317
• Combination Product (y/n): N
• PMA/PMN Number: K161777
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 09/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 01/31/2021
• Device Catalogue Number: 383531
• Device Lot Number: 8047612
• Date Manufacturer Received: 07/23/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention