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

Catalog Number 383516

Device Problem Stretched (1601)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/13/2023

Event Type  malfunction  

Event Description

It was reported that bd nexiva tubing expanded.The following information was received by the initial reporter with the verbatim: mds-received via phone call on 14-sep-2023.Customer stated that the 20 gauge nexiva ballooned up.1st customer response.Was there a delay of, or change in, the course of treatment due to the event?no delay or change in treatment.What type of procedure is being performed? cta.What was the medication/fluid in use at the time of the event? the solution used was contrast 370 and ns injected at 4.5 ml/sec.Where was the leakage? no leakage, the tubing expanded significantly.

Manufacturer Narrative

H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

No additional information.

Manufacturer Narrative

Investigation results: our quality engineer inspected the sample submitted for evaluation.Bd received one unsealed 20ga x 1.00in.Single port nexiva unit.Through the visual inspection, media is present, no packaging was provided and the extension tubing of the device appeared to be ¿ballooned¿.The clamp was not activated but there appeared to be a kink in the tubing where the clamp was present.The unit was flushed to inspect for any occlusion, but no occlusion was discovered.The unit was leak tested to analyze for any damage the ballooning may have caused, but no leak was found.The tubing was cut and microscopically analyzed for any adhesive overflow in the adapter that may have caused occlusion.No adhesive or occlusion were discovered.Your reported issue was confirmed.There was no physical evidence to conclude that your reported issue was related to the manufacturing process.Per the ifu(instructions for use), the maximum power injector pressure limit is 300psi.If this pressure limit is exceeded, ballooning is likely to occur.Additionally, a ballooned tubing may occur due to the tubing being kinked or occluded during pressure injection.A device history record review showed no non-conformances associated with this issue during the production of this batch.

• Brand Name: BD NEXIVA
• Type of Device: INTRAVASCULAR CATHETER
• 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: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 17843877
• MDR Text Key: 324593561
• Report Number: 1710034-2023-01129
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903835165
• UDI-Public: (01)30382903835165
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102520
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 383516
• Device Lot Number: 3087430
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/14/2023
• Initial Date FDA Received: 09/29/2023
• Supplement Dates Manufacturer Received: 11/02/2023
• Supplement Dates FDA Received: 11/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/29/2023
• 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