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

Catalog Number 393202

Device Problems Leak/Splash (1354); Defective Device (2588)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/16/2024

Event Type  Injury  

Manufacturer Narrative

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 broke the following information was received by the initial reporter with the following verbatim: during the removal of the venflon, even without forcing, a good part of the puncture of the cannula (really broken) remained in the vein.Consequence intervention surgical.

Manufacturer Narrative

No samples (including photos) were returned for the reported issue of ¿catheter broke / separated after placement¿ with lot number 1363218 regarding item # 393202, so retention samples were used for the investigation.The device history review (dhr) of material number 393202 with lot number 1363218 was checked and there was no quality notification found on this lot number from its production date to its dispatch on date.The investigation was carried out on 01 retention samples where the investigating team has tested the samples for catheter pull force and no catheter pull force was found out of specification in the retention sample.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.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.

Event Description

During the removal of the venflon, even without forcing, a good part of the puncture of the cannula (really broken) remained in the vein.Consequence intervention surgical.

• 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: 19128338
• MDR Text Key: 340445743
• Report Number: 2243072-2024-00553
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 05/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 393202
• Device Lot Number: 1363218
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/25/2024
• Initial Date FDA Received: 04/17/2024
• Supplement Dates Manufacturer Received: 05/15/2024
• Supplement Dates FDA Received: 05/21/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/29/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention