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

Device Problem Difficult or Delayed Activation (2577)

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

Event Date 02/02/2024

Event Type  malfunction  

Event Description

It was reported that bd nexiva diffusics 22g x 1.00 in needle disengagement was difficult the following information was provided by the initial reporter: needle mechanism would not detach from the cannula itself and the patient had to re-cannulated during use.

Manufacturer Narrative

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

Event Description

Needle mechanism would not detach from the cannula itself and the patient had to re-cannulated during use the patient had to be recannulated.

Manufacturer Narrative

Our quality engineer inspected the 1 photo submitted for evaluation.The reported issue of needle disengagement difficult was not confirmed upon inspection of the photo.The defect reported could not be observed in the supplied sample photo.A physical sample would be needed to investigate the reported defect.Bd cannot confirm the cause of the failure since no sample was returned for evaluation.We would be very interested in examining product that does not meet your expectations and our quality standards.Examination of the actual product involved may provide clarification as to the cause of the reported failure.A review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately.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.

• Brand Name: BD NEXIVA DIFFUSICS 22G X 1.00 IN
• 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: 18792482
• MDR Text Key: 336868298
• Report Number: 9610847-2024-00043
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: K123734
• 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: 02/29/2024

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: 383591
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/05/2024
• Initial Date FDA Received: 02/27/2024
• Supplement Dates Manufacturer Received: 02/29/2024
• Supplement Dates FDA Received: 02/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1