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

Catalog Number 383692

Device Problem Retraction Problem (1536)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/15/2024

Event Type  malfunction  

Event Description

It was reported that bd nexiva diffusics 22g x 1.00 in global stylet was difficult to remove the following information was provided by the initial reporter: unable to retract needle completely, needle stylet stuck with septum after advancement.Unable to retract needle completely, needle stylet stuck with septum.

Manufacturer Narrative

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

Manufacturer Narrative

Our quality engineer inspected the 1 photo and 1 sample submitted for evaluation.The reported issue of stylet difficult to remove was confirmed upon inspection of the sample.Analysis of the sample showed that there was damage to the cannula that affected the functionality of the device.Bd determined that the cause of the failure was related to our assembly process.A review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately.Production records were reviewed, and this batch meets our manufacturing specification requirements.We appreciate you taking the time to bring this observation to our attention.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.We regret any inconveniences this incident may have caused you and your facility.

Event Description

Has there been any patient impact (serious injury, medical intervention, change of treatment required)? no.Did malfunction caused needle stick injury to healthcare worker or patient? no.Have any other actions been taken? removed cannula and did new cannulation.

• Brand Name: BD NEXIVA DIFFUSICS 22G X 1.00 IN GLOBAL
• 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: 18839300
• MDR Text Key: 337089070
• Report Number: 9610847-2024-00054
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903836925
• UDI-Public: (01)00382903836925
• Combination Product (y/n): N
• Reporter Country Code: SA
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/25/2024

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: 383692
• Device Lot Number: 2297276
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/15/2024
• Initial Date FDA Received: 03/05/2024
• Supplement Dates Manufacturer Received: 03/25/2024
• Supplement Dates FDA Received: 03/25/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1