MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 20 G X 1.00 IN. BD NEXIVA¿ CLOSED IV CATHETER SYSTEM WITH DUAL PORT

Catalog Number 383536

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/18/2017

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.(b)(4).

Event Description

It was reported that the safety failed on a 20 g x 1.00 in.Bd nexiva¿ closed iv catheter system with dual port during use.No injury or medical intervention.

Manufacturer Narrative

Correction: date received by manufacturer: 09/18/2017.

Event Description

It was reported that the safety failed on a 20 g x 1.00 in.Bd nexiva¿ closed iv catheter system with dual port during use.No injury or medical intervention.

Manufacturer Narrative

Investigation summary: safety shield activation failure.Device/batch history record review: findings: the lot number 7131593 was manufactured on nfa line 1.Although there was 1 qn¿s ((b)(4)) initiated during its production, the failure was not relatable.In process samples including (but not limited to) correct assembly/proper retraction, machine caused damage and the occlusion test calibration all passed per specification.(b)(4) was in place during manufacturing under which 240 samples were pulled throughout the batch and tested for flashback.All samples tested passed.Representative sample analysis: received three nexiva 20ga units within sealed packages from lot number 7131593.All components were present and intact.Observed there was no mechanical/physical damage to any of the components.There were no wrinkles or kinks in the tubing.The cannula and catheter tips were acceptable per specifications and the lie distance was within the acceptable range of 0.001 - 0.031 inches.Flashback test: using a lab supplied artificial vein with a red dye/water mix performed a simulation of the venipuncture.Observed that upon penetration of the needle into the artificial vein; the initial flashback visualization could be seen rapidly in the chamber of the catheter/adapter.There were no obstructions inhibiting the flashback therefore, the unit demonstrated an acceptable flashback; fluid took less than one second to show a visible flow through the notch.Functional: the units were manually disengaged and retracted successfully and no drag/grinding was felt, the v-clip performed as intended and the needle stayed secured.Investigation conclusion: the representative units tested met all specification requirements.The failures experienced by the customer were not confirmed.The flashback and functional (disengagement) were successful.Reproduction of the failures that the customer experienced was not achieved with the evaluation and testing performed on the units received in the laboratory environment.Root cause description: the returned representative units did not display any adverse characteristics that would contribute to the defect the customer experienced.The defects described in the incident report could not be confirmed or replicated.The actual unit described in the incident report was not returned for evaluation.No root cause could be determined through the investigation: though the defect of "flashback (poor/no)" could not be confirmed, capa (b)(4) has been initiated to address the occurrence of the defect as stated in the verbatim of the pir.

• Brand Name: 20 G X 1.00 IN. BD NEXIVA¿ CLOSED IV CATHETER SYSTEM WITH DUAL PORT
• Type of Device: CLOSED IV CATHETER SYSTEM
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer (Section G): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 6879327
• MDR Text Key: 87863997
• Report Number: 1710034-2017-00235
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K102520
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 09/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 04/30/2020
• Device Catalogue Number: 383536
• Device Lot Number: 7131593
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/11/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other