MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD NEXIVA DIFFUSICS 22G X 1.00 IN; INTRAVASCULAR CATHETER

Catalog Number	383591
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd nexiva diffusics 22g x 1.00 in had a crack it was reported by customer that they went to flush it and towards the end of the saline flush it started leaking.She found a crack on the same little piece.Verbatim: from customer- ¿several months ago i had a patient's iv leak due to part of the iv being cracked.When we hooked up the power injector to the iv and unclamped it, it leaked and poured blood all over the patient and the floor because it was cracked and there was no longer a seal.We thought it was something totally random and moved on.But another tech told me that 2 weeks ago the same exact thing happened at one of our other offices, he started an iv, hooked up saline and it started leaking because there was a crack on the piece we connect contrast/saline to and then today the same thing happened to our tech assistant.She started an iv, went to flush it and towards the end of the saline flush it started leaking.She found a crack on the same little piece.She had to restart the patient¿s iv because there's just no way around that crack.¿ the one that happened today¿.We have the lot number 4247514 i don¿t know if this has been reported by anyone else who uses this item or not.And unfortunately i don¿t have the lot numbers for the other occurrences.¿.
Additional Manufacturer Narrative
If a device evaluation and/or device history review is completed, a supplemental report will be filed.B3.The date received by manufacturer has been used for this field.
Additional Manufacturer Narrative
Investigation results: a device history record review was completed by our quality engineer team for provided material number 383591 and lot number 4247514.The review did not reveal any detected abnormalities during the production process that could have contributed to this defect and all quality tests were found to be within specification.As a sample was unavailable for return, a thorough sample investigation could not be completed.Based on the investigation results, an exact cause for this incident could not be identified.There are quality controls currently in place to detect this type of defect during the production process.Further action has not been determined necessary at this time.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 or Problem Description
No additional information.

• Brand Name: BD NEXIVA DIFFUSICS 22G X 1.00 IN
• 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 ; 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: 21687836
• Report Number: 9610847-2025-00070
• Device Sequence Number: 21140782
• Product Code: FOZ
• UDI-Device Identifier: 00382903835911
• UDI-Public: (01)00382903835911(11)240930(17)270831(10)4247514
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K173354
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2025

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
• Operator of Device: Health Professional
• Device Catalogue Number: 383591
• Device Lot Number: 4247514
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2025
• Supplement Date Received by Manufacturer: 04/08/2025
• Initial Report FDA Received Date: 03/25/2025
• Supplement Report FDA Received Date: 04/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/30/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown