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

Catalog Number 391593

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

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

Event Date 03/22/2024

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 foreign matter on it the following information was received by the initial reporter with the following verbatim when the nurse took out the bd venflon i 18g cannula from the package, she found liquid droplets inside the catheter lumen upon removal of the needle (stylet).This happened while checking the stylet before insertion of the cannula to the patient's arm.

Event Description

When the nurse took out the bd venflon i 18g cannula from the package, she found liquid droplets inside the catheter lumen upon removal of the needle (stylet).This happened while checking the stylet before insertion of the cannula to the patient's arm.

Manufacturer Narrative

01 sample was received by bd for evaluation.A quality engineer was able to inspect the returned samples for the reported issue of foreign matter from lot # 3335319 product # 391593.The investigating team has also used the retention samples of lot # 3335319 product # 391593 for investigating the reported defect.Return sample review: the original customer returned sample was used to investigate the complaint of foreign matter and it was found that the sample did not show any defect of liquid droplets/foreign matter.Thus, the defect of foreign matter/ droplets inside the catheter lumen cannot be confirmed.Retention sample review: the investigation was conducted on 01 retention sample where the investigating team has visually tested the samples for foreign matter and no liquid droplets/foreign matter was found in the 01-retention sample.Thus, the defect of foreign matter/ droplets inside the catheter lumen cannot be confirmed.The complaint cannot be confirmed.Complaints received for this device and reported condition will continue to be tracked and trended.If samples are received in the future the complaint will be reopened for further investigation.

• 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: 19117845
• MDR Text Key: 341038030
• Report Number: 2243072-2024-00552
• 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: Foreign,Consumer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/01/2024

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: 391593
• Device Lot Number: 3335319
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/22/2024
• Initial Date FDA Received: 04/16/2024
• 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