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

Model Number 383517

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 03/28/2022

Event Type  malfunction  

Event Description

It was reported that the bd nexiva¿ closed iv catheter system needle contained foreign matter.The following information was provided by the initial reporter, translated from (b)(6) to english: "when preparing mr contrast enhancement examination for the patient, foreign bodies were found in the needle head of the one-time used indwelling needle, which was immediately replaced without adverse consequences.".

Manufacturer Narrative

Investigation summary: our quality engineer inspected the photograph submitted for evaluation.Upon inspection of the photo, it was identified that a black spec is located on the catheter tubing.It is difficult to identify if the black spec is embedded or attached to the lubrication on the outside of the catheter tubing as well as any features of the foreign.As the device is opened it is possible that the foreign was introduced during manufacturing/packaging of the device as well as in the clinical environment.Without the sample for further inspection and material testing it cannot be identified the origin of the foreign observed in the photo.A device history record review showed no non-conformance's associated with this issue during the production of this batch.Complaints received for this device and reported condition will continue to be tracked and trended.Investigation conclusion: the reported defect has been confirmed based on the photo evidence.A root cause cannot be established with certainty for the used device.

• Brand Name: BD NEXIVA¿ CLOSED IV CATHETER SYSTEM
• 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: 14164318
• MDR Text Key: 289901253
• Report Number: 1710034-2022-00203
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903835172
• UDI-Public: 30382903835172
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K183399
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 04/30/2024
• Device Model Number: 383517
• Device Catalogue Number: 383517
• Device Lot Number: 1120183
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/03/2021
• 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