MAUDE Adverse Event Report: BECTON DICKINSON BD VENFLON PRO SAFETY 22GA 0.9MM OD 25MM; INTRAVASCULAR CATHETER

Catalog Number 393222

Device Problem Material Protrusion/Extrusion (2979)

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

Event Date 03/19/2024

Event Type  malfunction  

Event Description

It was reported that bd venflon pro safety 22ga 0.9mm od 25mm safety mechanism failed the following information was provided by the initial reporter: cannulas are leaking, the safety mechanism has disintegrated, they are blunt the white "cube" with the safety mechanism has broken off during implantation when did the incident occur? during use.

Manufacturer Narrative

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

Manufacturer Narrative

As no sample and no photo were returned, further investigation cannot be performed.Visual inspection and functional test were performed per control plan during production.A review of past 12 months quality notification was performed.No similar quality notification was raised for the reported defect.Therefore, the root cause cannot be determined.Complaint trend would be monitored and complaint will be reopened when sample is returned.

Event Description

Cannulas are leaking, the safety mechanism has disintegrated, they are blunt the white "cube" with the safety mechanism has broken off during implantation when did the incident occur? during use.

Event Description

Cannulas are leaking, the safety mechanism has disintegrated, they are blunt the white "cube" with the safety mechanism has broken off during implantation when did the incident occur? during use.

Manufacturer Narrative

Edits to patient grid.As no sample and no photo were returned, further investigation cannot be performed.Visual inspection and functional test were performed per control plan during production.A review of past 12 months quality notification was performed.No similar quality notification was raised for the reported defect.Therefore, the root cause cannot be determined.Complaint trend would be monitored and complaint will be reopened when sample is returned.

• Brand Name: BD VENFLON PRO SAFETY 22GA 0.9MM OD 25MM
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 19056938
• MDR Text Key: 340460209
• Report Number: 2243072-2024-00515
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903932221
• UDI-Public: (01)00382903932221
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/27/2024

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: 393222
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/14/2024
• Initial Date FDA Received: 04/07/2024
• 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