MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD NEXIVA 20 GA X 1.00IN SP WITH MAXZERO; INTRAVASCULAR CATHETER

Catalog Number 383556

Device Problem Mechanical Problem (1384)

Patient Problem Hemolysis (1886)

Event Date 06/07/2023

Event Type  malfunction  

Event Description

It was reported that bd nexiva 20 ga x 1.00in sp with maxzero hemolyzed the following information was provided by the initial reporter: it was reported by customer that difficult intravenous line (iv) stick patient - patient with 2 iv sticks (nexiva iv equip) with flashes.Registered nurse (rn) unable to get pig tail line to draw.Labs drawn on 2nd stick ¿ hemolyzed.Delay in care - lab had to come draw.Patient drawn 90 minutes from order.Delay to get labs - awaiting results 2.15 hours later.Verbatim: rcc received a complaint via email.Email(s) attached.Difficult intravenous line (iv) stick patient - patient with 2 iv sticks (nexiva iv equip) with flashes.Registered nurse (rn) unable to get pig tail line to draw.Labs drawn on 2nd stick ¿ hemolyzed.Delay in care - lab had to come draw.Patient drawn 90 minutes from order.Delay to get labs - awaiting results 2.15 hours later.

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.

• Brand Name: BD NEXIVA 20 GA X 1.00IN 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 ; 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: 19021141
• MDR Text Key: 339135529
• Report Number: 9610847-2024-00078
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903835560
• UDI-Public: (01)00382903835560
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K183399
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 383556
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/08/2024
• Initial Date FDA Received: 04/02/2024
• 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