MAUDE Adverse Event Report: BECTON & DICKINSON BD VENFLON PRO SAFETY 20GA 1.1MM OD 32MM L; INTRAVASCULAR CATHETER

Catalog Number 393224

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 11/10/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that bd venflon pro safety 20ga 1.1mm od 32mm l had foreign matter the following information was provided by the initial reporter; after opening the packaging of the venflon pro safety, it was apparent that there was fiber residue on the outside of the catheter.

Manufacturer Narrative

Based on the returned photos, it is unable to determine what the foreign matter is.As no sample was returned, further investigation cannot be performed.Dhr was reviewed and no abnormality was reported.No similar quality notification was raised for the reported defect in the past 12 months.Therefore, the root cause cannot be determined.Complaint trend would be monitored and complaint will be reopened when sample is returned.

Event Description

After opening the packaging of the venflon pro safety, it was apparent that there was fiber residue on the outside of the catheter.

• Brand Name: BD VENFLON PRO SAFETY 20GA 1.1MM OD 32MM L
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON & DICKINSON; ruzgarlibahce mah s; sinan eroglu cad no 6; beykoz 34805 ; TU 34805
• Manufacturer (Section G): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18270432
• MDR Text Key: 329806678
• Report Number: 2243072-2023-02138
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: NA
• 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: 12/06/2023

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: 393224
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/06/2023
• Initial Date FDA Received: 12/05/2023
• Supplement Dates Manufacturer Received: 12/06/2023
• Supplement Dates FDA Received: 12/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/18/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1