MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD NEXIVA¿ DIFFUSICS¿ CLOSED IV SYSTEM; INTRAVASCULAR CATHETER

Catalog Number 383695

Device Problem Material Puncture/Hole (1504)

Patient Problem Pain (1994)

Event Date 01/13/2023

Event Type  malfunction  

Event Description

It was reported while using bd nexiva¿ diffusics¿ closed iv system there were holes in the catheter tip.This occurred 3 times.There was no report of patient impact.The following information was provided by the initial reporter: additional holes in the tip of the cannula bulge outwards.On the tip of the cannula, additional holes in the tip.The same problem was observed in the other cannulas in the package.

Manufacturer Narrative

Initial reporter facility name: (b)(6).A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported while using bd nexiva¿ diffusics¿ closed iv system there were holes in the catheter tip.This occurred 3 times.There was no report of patient impact.The following information was provided by the initial reporter: additional holes in the tip of the cannula bulge outwards.On the tip of the cannula, additional holes in the tip.The same problem was observed in the other cannulas in the package.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 14-feb-23.H6: investigation summary: our quality engineer inspected the 16 samples submitted for evaluation.The reported issues of difficult insertion (interlink) and catheter defective / damaged was not confirmed upon inspection and testing of the samples.Analysis of the samples showed that there were no abnormalities or defects present.Bd could not determine a manufacturing related root cause since the defects were not observed in the returned samples.Production records were reviewed, and this batch met our manufacturing product specification requirements.H3 other text : see h10.

• Brand Name: BD NEXIVA¿ DIFFUSICS¿ CLOSED IV SYSTEM
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• Manufacturer (Section G): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 16294462
• MDR Text Key: 308957466
• Report Number: 9610847-2023-00012
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: NA
• 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,Followup
• Report Date: 03/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 01/31/2024
• Device Catalogue Number: 383695
• Device Lot Number: 1021249
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/03/2021
• 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