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
Medical Device Problem Codes	Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Codes	Pain (1994); Burning Sensation (2146)
Date of Event	06/27/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A sample is available for evaluation.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem 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.
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 9610847-2019-00468
• Device Sequence Number: 19506486
• Product Code: FOZ
• UDI-Device Identifier: 30382903835509
• UDI-Public: 30382903835509
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K183399
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 06/27/2019
• Supplement Date Received by Manufacturer: 06/27/2019
• Initial Report FDA Received Date: 07/17/2019
• Supplement Report FDA Received Date: 08/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 56 YR