MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD NEXIVA 24 GA X 0.56IN SP WITH MAXZERO; INTRAVASCULAR CATHETER

Catalog Number 383550

Device Problems Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)

Patient Problems Pain (1994); Burning Sensation (2146)

Event Date 06/27/2019

Event Type  malfunction  

Manufacturer Narrative

A sample is available for evaluation.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that during insertion the needle went through the catheter with a bd nexiva 24 ga x 0.56 in sp with maxzero.The following information was provided by the initial reporter: our pre-procedure nurse inserted a piv on a pt pre procedure in iru.Before she inserted the needle, it didn¿t look like there¿s an issue with it.However, as soon as she inserted it on a patient, the pt complained of burning pain.The nurse decided then to pull out the needle from the patient and noted that the plastic split in half and the actual metal needle is outside the plastic.

Manufacturer Narrative

Investigation summary: a device history review was conducted for lot number 7327610.Our records show that this is the only instance of this issue occurring in this production batch.According to the sampling plan applied for product performance, this lot was accepted and released without defects being noted during the final assembly or visual inspections.Additionally, the punctured catheter observed in the submitted sample, prompted our quality engineers to review our manufacturing process; unfortunately they were unable to replicate the non-conformance or identify potential areas of concern.Without the ability to replicate this failure mode and based on their observations during their review, the root cause for this complaint could not be associated with the manufacturing process at the conclusion of our review.Based on investigation results the root cause cannot be determined.Possibly, this defect could be related with an inadequate handling after to open the package y/o device placement.

Event Description

It was reported that during insertion the needle went through the catheter with a bd nexiva 24 ga x 0.56in sp with maxzero.The following information was provided by the initial reporter: our pre-procedure nurse inserted a piv on a pt pre procedure in iru.Before she inserted the needle, it didn¿t look like there¿s an issue with it.However, as soon as she inserted it on a patient, the pt complained of burning pain.The nurse decided then to pull out the needle from the patient and noted that the plastic split in half and the actual metal needle is outside the plastic.

• Brand Name: BD NEXIVA 24 GA X 0.56IN SP WITH MAXZERO
• 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
• MDR Report Key: 8798485
• MDR Text Key: 154554690
• Report Number: 9610847-2019-00468
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903835509
• UDI-Public: 30382903835509
• Combination Product (y/n): N
• PMA/PMN Number: K183399
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Type of Report: Initial,Followup
• Report Date: 08/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2020
• Device Catalogue Number: 383550
• Device Lot Number: 7327610
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2019
• Initial Date Manufacturer Received: 06/27/2019
• Initial Date FDA Received: 07/17/2019
• Supplement Dates Manufacturer Received: 06/27/2019
• Supplement Dates FDA Received: 08/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 56 YR