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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD NEXIVA¿ CLOSED IV CATHETER SYSTEM; INTRAVASCULAR CATHETER
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BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD NEXIVA¿ CLOSED IV CATHETER SYSTEM; INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 383532
Device Problems Physical Resistance (2578); Device Operates Differently Than Expected (2913); Noise, Audible (3273)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/10/2018
Event Type  malfunction  
Manufacturer Narrative
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 the safety mechanism failed to work correctly on a bd nexiva¿ closed iv catheter system as the mechanism was found to be "very stiff to pull" and made a "grinding/sound feeling." there was no report of exposure, serious injury, or medical intervention.
 
Manufacturer Narrative
Correction: due to an it issue beginning on 7/3/2018, previously filed emdrs did not contain required fields.This supplemental emdr is filed to provide the following omitted fields: device returned to manufacture: yes.
 
Event Description
It was reported with the use of the bd nexiva¿ closed iv catheter system there was an issue with leakage.It was stated ¿after the device was used on the patient, blood leaked.The leaked point is unknown however it must be between the wings and the extube.¿ there was no report of injury or further medical intervention.
 
Manufacturer Narrative
Investigation summary: device/batch history record review showed the lot was built and packaged on nfa line 2 from (b)(6) 2017 through 25oct2017 for the quantity of 383,050ea.All required challenge samples and testing during the build of the catheters was performed per specifications, in accordance with the in-process sampling plans.A related qn for ¿failed retraction¿ was initiated; disposition of the product, root cause and corrective action were applied according to the quality control plan.End user risk analysis (eura) review indicates causes of the difficult retraction include the washer binding on the cannula, inadequate lubrication, and excessive interference with the septum.None of these issues were confirmed upon investigation as the provided sample exhibited a smooth retraction.Visual analysis observations and testing: received 1 nexiva 22ga used unit along with a piece top of web (packaging) from lot number 7290663.All components were present and intact.Visual/microscopic evaluation showed no physical-mechanical damage was observed on any of the components of the unit.No traces of adhesive were present on any area of the unit.Simulation test performed inn an attempt to recreate the customer¿s experience.The unit successfully disengaged with minor grinding felt.The needle was measured in three different areas and the average measurement was.0225 (acceptable per specification).The specification for od as per drawing is.0223-/+.0003.The large hole of the retaining washer measured at 0.0236, which met specification that is 0.0232 +/- 0.0005.No physical-mechanical damage was found on any of the components of the unit and the needle successfully disengaged without resistance.Although minor grinding was felt, the unit successfully disengaged without resistance during simulation, since no physical-mechanical damage was observed and the cannula and washer were within specification; the root cause related to the reported incident could not be determined.A formal corrective action will not be initiated at this time.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.
 
Event Description
It was reported that the safety mechanism failed to work correctly on a bd nexiva¿ closed iv catheter system as the mechanism was found to be "very stiff to pull" and made a "grinding/sound feeling." there was no report of exposure, serious injury, or medical intervention.
 
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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 Key7562015
MDR Text Key109907720
Report Number1710034-2018-00246
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier30382903835325
UDI-Public30382903835325
Combination Product (y/n)N
PMA/PMN Number
K161777
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Type of Report Initial,Followup,Followup
Report Date 09/05/2018
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 Other
Device Expiration Date09/30/2020
Device Catalogue Number383532
Device Lot Number7290663
Initial Date Manufacturer Received 05/10/2018
Initial Date FDA Received06/01/2018
Supplement Dates Manufacturer Received05/10/2018
05/10/2018
Supplement Dates FDA Received08/01/2018
09/13/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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