MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD NEXIVA 20 GA X 1.25IN SP WITH MAXZERO; INTRAVASCULAR ADMINISTRATION SET

Catalog Number 383557

Device Problems Defective Device (2588); Insufficient Information (3190)

Patient Problems Hemolysis (1886); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/28/2024

Event Type  malfunction  

Manufacturer Narrative

H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.

Event Description

It was reported that bd nexiva 20 ga x 1.25in sp with maxzero hemolysis the following information was provided by the initial reporter: since december/january 2023-2024 uz gent has been using the nexiva catheters as a result of backorders of their regular catheters (autguard).They have notices an increased hemolysis level on er department every since (+/-10%).¿ was obvious after the sampling that the sample was hemolyzed? = no, we did not evaluate the sample macroscopically.Internal lab criteria classify a sample as hemolyzed when the h-index measured on architect c16000 is >100.By evaluating our hemolysis index a the emergency department, we observed that the number of samples with a h-index >100 increased from 6-7% to 9.5-10% ¿ was there any delay in treatment? = this can not be deduced from the obtained data.¿ any negative consequences for the patient? = this can not be deduced from the obtained data.

Event Description

We have this issue with all the nexvia catheters that we use at the emergency department, which is lotnumber independent.

Manufacturer Narrative

As no physical sample, picture sample, or lot number was provided for evaluation by our quality engineer team, a complete investigation could not be performed.There are current quality controls in place to detect this type of product malfunction during the production process.Based on the limited investigation results, a cause for the reported incident could not be determined.Should you again experience any problems with our product we would appreciate the opportunity to conduct a thorough analysis.Examination of the product involved may provide clarification as to the cause for the reported failure.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.

Manufacturer Narrative

As no physical sample, picture sample, or lot number was provided for evaluation by our quality engineer team, a complete investigation could not be performed.There are current quality controls in place to detect this type of product malfunction during the production process.Based on the limited investigation results, a cause for the reported incident could not be determined.Should you again experience any problems with our product we would appreciate the opportunity to conduct a thorough analysis.Examination of the product involved may provide clarification as to the cause for the reported failure.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.

Event Description

No additional information.

• Brand Name: BD NEXIVA 20 GA X 1.25IN SP WITH MAXZERO
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• 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: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 19011678
• MDR Text Key: 339126148
• Report Number: 9610847-2024-00073
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 30382903835578
• UDI-Public: (01)30382903835578
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K170336
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 383557
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/25/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1