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

Catalog Number 383536

Device Problem Defective Device (2588)

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

Event Date 02/01/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.(b)(6).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 during use of the bd nexiva dual port that the q-site connector is defective.

Manufacturer Narrative

H.6.Investigation: dhr review: 8275650 (nexiva lot): one non-related qn was initiated on this lot, disposition, root cause and corrective actions were applied as per control plan.All other required challenge samples, set-up and in process testing was performed in accordance with the quality plan.Q-syte sub assembly lots: 8255628: ¿ 1 potentially related qn (b)(4) was initiated during production, disposition, root cause and corrective actions were applies per control plan.All other challenge, set up and in process samples were applied per specifications 8255624: 8262828: no qn¿s were initiated during the production of the above 2 lots all challenge, set up and in process samples were performed per specifications received one q-syte assembly along with a nexiva top web (packaging) portion from lot number 8275650.Visual/microscopic evaluation: the top septum disk and a portion of the septum body was damaged (teared) the top body (neck) was damaged (cracked) the edge of the top body was damaged (cracked) traces of blood were observed note: pictures reflect similar findings.A definite cause that contributed to the damage observed on the used unit received could not be determined, damage appears to be caused by external forces applied to the unit.Mfg.Eng.Confirmed the damage was not caused during the q-syte manufacturing process and checked the nexiva line but could not confirm or find any process related cause for this type of damage.

Event Description

It was reported that during use of the bd nexiva dual port that the q-site connector is defective.

• Brand Name: BD NEXIVA DUAL PORT
• Type of Device: INTERVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 8312825
• MDR Text Key: 135352833
• Report Number: 1710034-2019-00149
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903835363
• UDI-Public: 30382903835363
• Combination Product (y/n): N
• PMA/PMN Number: K161777
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 05/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 09/30/2021
• Device Catalogue Number: 383536
• Device Lot Number: 8275650
• Date Manufacturer Received: 02/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other