MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD NEXIVA DUAL PORT WITH Q-SYTE; INTRAVASCULAR CATHETER

Catalog Number 383531

Device Problem Defective Component (2292)

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

Event Date 02/05/2022

Event Type  malfunction  

Event Description

It was reported that the bd nexiva dual port with q-syte had the septum become deformed.The following information was provided by the client: "when attempted to connect to an iv line after venipuncture, the hcp discovered that the septum of q-syte was deformed.".

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 the bd nexiva dual port with q-syte had the septum become deformed.The following information was provided by the client: "when attempted to connect to an iv line after venipuncture, the hcp discovered that the septum of q-syte was deformed.".

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 2022-03-22.H6: investigation summary: our quality engineer inspected the sample and photographs submitted for evaluation.Bd received one standalone q-syte along with a 24g x 0.75in.Nexiva product label from lot number 1155068.Additionally, five photos were received for investigation.A gross visual inspection of the returned unit found that the septum was pushed in.The reported issue was confirmed.This was physical/mechanical evidence to confirm and support a manufacturing process related issue for the reported defect relating to insufficient adhesive.Microscopic inspection of the q-syte found that adhesive was not uniformly present on the rim of the q-syte top body.Additionally, the bottom side of the top disk had no adhesive.These observations indicate a possibility of inadequate bond at time of manufacture.No damage to the body of the device was noted, making insufficient adhesive the most likely root cause of the reported defect.During manufacturing, low bond strength (or insufficient adhesive), septum misorientation, damage to the top body of the q-syte, and damaged tooling may result in the septum being pushed in.Our operator-controlled checks for bond strength and septum damage are performed to mitigate the risk from this type of defect.Additionally, preventative maintenance (pm) is performed to ensure tooling is replaced per the quality plan and the equipment is functioning properly.Pm records were inspected and found to up to date during production of the involved sub-lots.A device history record review showed no non-conformances associated with this issue during the production of this batch.H3 other text : see h10.

• Brand Name: BD NEXIVA DUAL PORT WITH Q-SYTE
• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13863679
• MDR Text Key: 287792757
• Report Number: 1710034-2022-00142
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903835318
• UDI-Public: 0130382903835318
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K183399
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/01/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2024
• Device Catalogue Number: 383531
• Device Lot Number: 1155068
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/07/2022
• Initial Date FDA Received: 03/23/2022
• Supplement Dates Manufacturer Received: 04/01/2022
• Supplement Dates FDA Received: 04/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/04/2021
• 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