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

Catalog Number 391591

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

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

Event Date 04/06/2024

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 rust the following information was received by the initial reporter with the following verbatim: when venflon i 22g taken out of package.Rust found at the notch(instaflash needle) of needle.

Event Description

When venflon i 22g taken out of package.Rust found at the notch(instaflash needle) of needle.

Manufacturer Narrative

A quality engineer inspected the 02 photographs of lot # 3342742, material # 391591 submitted for evaluation.The reported issue was ¿foreign matter¿.Physical samples not submitted for evaluation.A review of our risk management document was performed and indicates that the potential risk of the reported event was assessed appropriately.Production records were reviewed, and this batch meets our specification requirements.Customer photographs of samples review: the photos of venflon i 22g lot # 3342742, material # 391591 received and evaluated.First photograph shows the cannula with instaflash notch visible.No signs of rust on cannula.Second photograph shows the back side of a unit pack showing lot number and other product details.The defect of rusted needle or foreign matter cannot be confirmed based on photographs.Retention sample review: investigation on the retained samples at our end for the lot # 3342742 material # 391591 carried out.The retention samples did not show any sign of rust or foreign matter.Device history record review: the device history record review was completed for provided lot # 3342742 material # 391591.There was no rejected inspections or quality notifications during the production of the provided lot number.

• 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: 19210586
• MDR Text Key: 341843957
• Report Number: 2243072-2024-00579
• 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: 05/22/2024

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: 391591
• Device Lot Number: 3342742
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/06/2024
• Initial Date FDA Received: 04/29/2024
• Supplement Dates Manufacturer Received: 05/22/2024
• Supplement Dates FDA Received: 05/23/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/08/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1