MAUDE Adverse Event Report: BECTON DICKINSON BD VENFLON I; PERIPHERAL IV CATHETERS.

Catalog Number 391591

Device Problem Break (1069)

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

Event Date 02/17/2024

Event Type  malfunction  

Event Description

It was reported that bd venflon i catheter tip becomes damaged.The following information was provided by the initial reporter: while doing iv cannulation, the catheter tip got peel off.Total 3 iv cannulas were used and all the three cannulas tip got peel off.

Manufacturer Narrative

H.3.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.In this mdr, bd franklin lakes, nj has been listed in sections d.3.And g.1.As the manufacturing site.

Manufacturer Narrative

The photo of package only (no picture available of the defective catheter tip) was received by bd for evaluation.After the review of venflon i 22g from lot #3313368 regarding item #391591 with the reported issue that catheter tip integrity.The investigation and simulation were carried out on 01 retention sample where the investigating team has visually inspected the sample for catheter tip damage and no catheter tip damage was found in the 01 retention sample.The exact root cause can only be determined if we receive the original sample.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.H3 other text : see h10 manufacture narrative.

Event Description

While doing iv cannulation, the catheter tip got peel off.Total 3 iv cannulas were used and all the three cannulas tip got peel off.

• Brand Name: BD VENFLON I
• Type of Device: PERIPHERAL IV CATHETERS.
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18876382
• MDR Text Key: 337467631
• Report Number: 2243072-2024-00268
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903915910
• UDI-Public: (01)00382903915910
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: UNK
• 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: 04/26/2024

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: 3313368
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/17/2024
• Initial Date FDA Received: 03/11/2024
• Supplement Dates Manufacturer Received: 04/26/2024
• Supplement Dates FDA Received: 05/02/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/09/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1