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

Model Number	383538
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd nexiva¿ closed iv catheter system - dual port had the catheter adapter deformed.The following information was provided by the initial reporter: "q-syte needless connector that comes in product packaging is not allowing a syringe to be placed on end of it on several different occasions.".
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Initial reporter facility name: (b)(6) medical center.
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Initial reporter facility name: (b)(6) medical center.
Event or Problem Description
It was reported that bd nexiva¿ closed iv catheter system - dual port had the catheter adapter deformed.The following information was provided by the initial reporter: "q-syte needless connector that comes in product packaging is not allowing a syringe to be placed on end of it on several different occasions.".
Event or Problem Description
It was reported that bd nexiva¿ closed iv catheter system - dual port had the catheter adapter deformed.The following information was provided by the initial reporter: "q-syte needless connector that comes in product packaging is not allowing a syringe to be placed on end of it on several different occasions.".
Additional Manufacturer Narrative
H6: investigation summary: our quality engineer inspected the sample submitted for evaluation.Bd received two top web samples from lot 1147990, one bd 10ml posiflush syringe, and one q-syte device.During the visual/microscopic examination, it was observed that the top disk of the q-syte had been stretched and did not have a slit in it.The stretched top disk indicates that a force could have been applied to it, which resulted in the middle of the disk to be visibly deeper than in an assembled unit.It also explains some surface damage to the center of the top disk.This observation and conclusions were supported by the report of connection issues.The missing slit prevented connection to the q-syte and would also explain no flow, confirming the reported defects.Missing slits can occur during the manufacturing process; therefore, the defect was related to manufacturing.Preventative maintenance and quality inspections are performed at regular intervals to mitigate the risk from this type of defect.A device history record review showed no non-conformances associated with this issue during the production of this batch.

• Brand Name: BD NEXIVA¿ CLOSED IV CATHETER SYSTEM - DUAL PORT
• Common Device Name: 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13444103
• Report Number: 1710034-2022-00048
• Device Sequence Number: 11283670
• Product Code: FOZ
• UDI-Device Identifier: 30382903835387
• UDI-Public: 30382903835387
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K183399
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/14/2022

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
• Operator of Device: Other
• Device Expiration Date: 05/31/2024
• Device Model Number: 383538
• Device Catalogue Number: 383538
• Device Lot Number: 1147990
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2022
• Supplement Date Received by Manufacturer: 02/14/2022
• Initial Report FDA Received Date: 02/03/2022
• Supplement Report FDA Received Date: 02/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/28/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown