MAUDE Adverse Event Report: BD MEDICAL, MEDICATION DELIVERY SOLUTIONS BD VENFLON CATHETER; INTRAVASCULAR CATHETER

Catalog Number 393232

Device Problem Device Markings/Labelling Problem (2911)

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

Event Date 03/21/2024

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 catheter had incorrect label information the following information was received by the initial reporter with the following verbatim venflon i in venflpn pro contained boxes.Two boxes.

Manufacturer Narrative

No samples (including photos) were returned for the reported issue of ¿mixed product / lots¿ with lot number 3361353 regarding item # 393232.The device history review (dhr) of material number 393232 with lot number 3361353 was checked and there was no quality notification found on this lot number from its production date to its dispatch on date.The investigation and simulation were not carried out on retention sample because boxes of venflon i and venflon pro were mixed, and we have only one box (25 samples) of retention samples.The exact root cause can only be determined if we receive the original sample.The root cause cannot be determined.The complaint cannot be investigated further.

Event Description

Venflon i in venflpn pro contained boxes.Two boxes.

• Brand Name: BD VENFLON CATHETER
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BD MEDICAL, MEDICATION DELIVERY SOLUTIONS; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BD MEDICAL, MEDICATION DELIVERY SOLUTIONS; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 19112397
• MDR Text Key: 340567685
• Report Number: 2243072-2024-00547
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/15/2024

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: 393232
• Device Lot Number: 3361353
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/21/2024
• Initial Date FDA Received: 04/15/2024
• Supplement Dates Manufacturer Received: 05/15/2024
• Supplement Dates FDA Received: 05/16/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/11/2024
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1