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

Model Number 383532

Device Problem Leak/Splash (1354)

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

Event Date 12/13/2019

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 blood leaked from the bd nexiva¿ closed iv catheter system cannula tubing during a blood transfusion once it had started.The following information was provided by the initial reporter: "the incident happened on friday (b)(6) 2019 during a blood transfusion on a patient, a member of staff noticed that there appeared to be blood coming from the cannula tubing once the transfusion had commenced.".

Event Description

It was reported that blood leaked from the bd nexiva¿ closed iv catheter system cannula tubing during a blood transfusion once it had started.The following information was provided by the initial reporter: "the incident happened on (b)(6)2019 during a blood transfusion on a patient, a member of staff noticed that there appeared to be blood coming from the cannula tubing once the transfusion had commenced.".

Manufacturer Narrative

H.6.Investigation summary our quality engineer inspected the representative samples and photographs submitted for evaluation.Bd received three representative units from catalog number 383532, lot number 9050711.In addition, two photographs were also submitted which displayed the label information.Through the visual examination, the units were inspected for any cuts/slit, damage, or kinks in the device that may cause leakage.A leak test was performed where leakage was not observed.The returned representative units provided for evaluation met and performed per the required manufacturing specifications.There was no physical/mechanical evidence to confirm and support a manufacturing process related issue for the failure stated reported.Examination of the actual product involved may provide clarification as to the cause for the reported failure.A device history record review showed no non-conformances associated with this issue during the production of this batch.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends h3 other text : see section h.10.

• 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 Key: 9535817
• MDR Text Key: 179324584
• Report Number: 1710034-2019-01372
• 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: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 02/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 01/31/2022
• Device Model Number: 383532
• Device Catalogue Number: 383532
• Device Lot Number: 9050711
• Date Manufacturer Received: 12/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other