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

Catalog Number 393224

Device Problem Fitting Problem (2183)

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

Event Date 12/23/2023

Event Type  malfunction  

Event Description

It was reported that bd venflon pro safety 20ga 1.1mm od 32mm l luer fittings were incompatible.The following information was provided by the initial reporter: original message from the customer: "adapter does not fit on pvk.No blood could be accepted.It had to be pricked twice.Ok for 14 year olds, not for small children".

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.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

Original message from the customer: "adapter does not fit on pvk.No blood could be accepted.It had to be pricked twice.Ok for 14 year olds, not for small children.".

• Brand Name: BD VENFLON PRO SAFETY 20GA 1.1MM OD 32MM L
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore NJ 07417
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18538303
• MDR Text Key: 333329180
• Report Number: 2243072-2024-00036
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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: 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: Other
• Device Catalogue Number: 393224
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/27/2023
• Initial Date FDA Received: 01/18/2024
• Supplement Dates Manufacturer Received: 02/29/2024
• Supplement Dates FDA Received: 02/29/2024
• 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