MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD NEXIVA DUAL PORT 22GA 1.00IN (0.9 MM X 25 MM); INTERVASCULAR CATHETER

Catalog Number 383532

Device Problems Leak/Splash (1354); Device Slipped (1584)

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

Event Date 04/10/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.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 bd nexiva dual port 22ga 1.00in (0.9 mm x 25 mm) experienced loose closure.The following information was provided by the initial reporter: part no.: 383532, batch/lot: 9014995.Description of complaint: it was reported that when ¿starting the ivs, they get a frequent surprise with the loose plastic part and blood will end up squirting or running out onto the floor.¿.

Manufacturer Narrative

Dhr: lot was built and packaged on nfa line 2 from 16jan2019 through 26jan2019 for the quantity of 302,410 ea.All required challenge samples and testing during the build of the catheters was performed per specifications, in accordance with the in-process sampling plans.Although units were not returned for investigation; three photos were provided for observation of this incident.All 3 photos looked to be identical and shown the following: one opened package (top web / label was peeled back) shown a 22ga bd nexiva closed iv catheter dual port unit inside.All components were present and intact.The vent plug was circled in red.One sealed package (view of bottom web / clear blister) shown a 22ga bd nexiva closed iv catheter dual port unit inside.All components were present and intact less the vent plug which shown to be loosened from the luer adapter of the nexiva unit.There was a red circle calling attention to the loosened vent plug.One sealed package (view of top web / label) from lot 9014995.There was no visible damage to the packaging.Visual / microscopic observation: testing could not be conducted as units were not provided for this incident, therefore the defect of (1) blood excess / splash / spill / exposure was not confirmed and the photos did not provide sufficient evidence.The photos disclosed that there was a unit within a sealed package that had the vent plug loosened from one port of the dual adapter, hence confirming the reported defect of (2) catheter defective / damaged (loose plastic part).Conclusion(s): in regards to the defect of (1) blood excess / splash /spill /exposure: indeterminate ¿ although units were not provided for observation and testing of this incident and the photos did not provide sufficient evidence to confirm the alleged defect; based on the verbiage in the event description of the pir ¿they get a frequent surprise with the loose plastic part and blood will end up squirting or running out onto the floor¿, it is noted that leakage could occur from the luer adapter if the vent plug is not attached.In regards to the defect (2) catheter defective / damaged: design : also based on the same verbiage of ¿they get a frequent surprise with the loose plastic part and blood will end up squirting or running out onto the floor¿ and the observation of the provided photos the failure was confirmed to be loose/missing vent plug which was identified and confirmed for this incident and is a known issue.*the vent plug is inserted into the luer adapter at a specified force during manufacturing.This is a design issue; after the nexiva product goes through sterilization the fit between the flow plug and luer adapter becomes loose due to material relaxation.Per the ifus: catheter insertion: - inspect the catheter system.Check that the clamp (5) is not engaged and that the vent plug (7) is secure.

Event Description

It was reported that the bd nexiva dual port 22ga 1.00in (0.9 mm x 25 mm) experienced loose closure.The following information was provided by the initial reporter: part no.: 383532.Batch/lot: 9014995.Description of complaint: it was reported that when ¿starting the ivs, they get a frequent surprise with the loose plastic part and blood will end up squirting or running out onto the floor.¿.

• Brand Name: BD NEXIVA DUAL PORT 22GA 1.00IN (0.9 MM X 25 MM)
• Type of Device: INTERVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 8556939
• MDR Text Key: 145635579
• Report Number: 1710034-2019-00461
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903835325
• UDI-Public: 30382903835325
• Combination Product (y/n): N
• PMA/PMN Number: K183399
• 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: 06/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 12/31/2021
• Device Catalogue Number: 383532
• Device Lot Number: 9014995
• Date Manufacturer Received: 04/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other