MAUDE Adverse Event Report: BECTON DICKINSON BD NEXIVA¿ CLOSED IV CATHETER SYSTEM ¿ SINGLE PORT WITH MAXZERO¿; INTRAVASCULAR CATHETER

Model Number	383551
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while using bd nexiva¿ closed iv catheter system ¿ single port with maxzero¿ the tubing was found to be deformed.The following information was provided by the initial reporter: material# 383551, it was reported tubing is damaged lot# unknown per customer.Extension tubing looks to be dilated.
Additional Manufacturer Narrative
Date of event is unknown.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.Medical device expiration date: unknown.Device manufacture date: unknown.There are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.
Event or Problem Description
It was reported while using bd nexiva¿ closed iv catheter system ¿ single port with maxzero¿ the tubing was found to be deformed.The following information was provided by the initial reporter: material# 383551 it was reported tubing is damaged lot# unknown per customer.Extension tubing looks to be dilated.
Additional Manufacturer Narrative
The following fields were updated due to additional information: device available for eval yes, returned to manufacturer on: 2022-02-08 investigation summary our quality engineer inspected the sample and photograph submitted for evaluation.Bd received one used unit and one photo.Upon inspection of the unit, it was observed that the extension tubing was ballooned confirming the reported defect.The ifu states a maximum power injector pressure limit setting of 300 psi.Exceeding specification can result in the ballooning of the extension tubing.Ballooning of tubing may also occur if there is an obstruction or kinks in the tubing during pressure injection.If a manufacturing related obstruction was present, it would result in the flow rate being slow or completely occluded during flush and flashback.This would likely result in the clinician identifying a defect before connecting an iv.Regardless, the unit was microscopically inspected for any obstructions and none were found.As no obstructions were located, kinking of the tubing or exceeding the rated pressure remain as potential root causes both of which would be user related.A device history record review could not be performed as the lot number is unknown.

• Brand Name: BD NEXIVA¿ CLOSED IV CATHETER SYSTEM ¿ SINGLE PORT WITH MAXZERO¿
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13402283
• Report Number: 2243072-2022-00118
• Device Sequence Number: 4897992
• Product Code: FOZ
• UDI-Device Identifier: 30382903835516
• UDI-Public: 30382903835516
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/18/2022

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 Model Number: 383551
• Device Catalogue Number: 383551
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2022
• Supplement Date Received by Manufacturer: 02/18/2022
• Initial Report FDA Received Date: 01/31/2022
• Supplement Report FDA Received Date: 03/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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