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

Catalog Number 383592

Device Problem Difficult or Delayed Separation (4044)

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

Event Date 01/23/2024

Event Type  malfunction  

Event Description

It was reported that bd nexiva diffusics 20g x 1.00 in needle disengagement was difficult it was reported by the customer reported while starting iv on the patient with 20g diffusics, after inserting the needle in the vein, there was no flash back in the catheter or the attached pigtail, but blood started dripping from the joint where the white and the grey plastics meet.So advanced the catheter and pulled the needle out and a piece of metal fell from the grey piece.The needle did not come out attached to the grey piece.Showed the situation to a colleague.Then pulled the grey piece out manually and the iv flushed fine.Verbatim: hello bd team, good morning.On 01/23/2024, we had a safety event reported for bd item # 383592 (nexiva diffusics).Let¿s identify this as bd 262, as a reference number.The defective product is available for pick up from defect depot.Please contact ashlee shepard (copied here) with any questions you may have about pick up.Based on the information provided below, could you start a product quality report? bd 262: reported date: 01/23/2024; event date: 01/23/2024; item number: 383592; lot number: 3124280; item retained in defect depot?: yes; picture: yes, attached; patient harm: none; area: computerized tomography (ct) (roc) event details: ¿while starting iv on the patient with 20g diffusics, after inserting the needle in the vein, there was no flash back in the catheter or the attached pigtail but blood started dripping from the joint where the white and the grey plastics meet.So advanced the catheter and pulled the needle out and a piece of metal fell from the grey piece.The needle did not come out attached to the grey piece.Showed the situation to a colleague.Then pulled the grey piece out manually and the iv flushed fine.¿.

Manufacturer Narrative

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

Event Description

No additional information.

Manufacturer Narrative

A device history record review was completed by our quality engineer team for provided material number 383592 and lot number 3124280.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.Should you again experience any problems with our product we would appreciate the opportunity to conduct a thorough analysis.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.

• Brand Name: BD NEXIVA DIFFUSICS 20G 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: 18722642
• MDR Text Key: 335596287
• Report Number: 9610847-2024-00033
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123734
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/28/2024

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: Other
• Device Catalogue Number: 383592
• Device Lot Number: 3124280
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/25/2024
• Initial Date FDA Received: 02/16/2024
• Supplement Dates Manufacturer Received: 03/28/2024
• Supplement Dates FDA Received: 03/29/2024
• 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