MAUDE Adverse Event Report: BECTON DICKINSON CATHENA 18GX1.25IN WINGED BC; INTRAVASCULAR CATHETER

Catalog Number 386808

Device Problem Leak/Splash (1354)

Patient Problem Extravasation (1842)

Event Date 10/13/2023

Event Type  malfunction  

Event Description

It was reported that bd cathena 18gx1.25in winged bc leaked here are the batch numbers currently in use: 3111826 ; 2299806 ; 2312531.I don't have any photos to provide.Consequences: extravasation of contrast medium.In some cases, radiology has been performed to visualize the extravasation.

Manufacturer Narrative

H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.B3.The date received by manufacturer has been used for this field.

Event Description

Here are the batch numbers currently in use: 3111826 ; 2299806 ; 2312531.I don't have any photos to provide.Consequences: extravasation of contrast medium.In some cases, radiology has been performed to visualize the extravasation.

Manufacturer Narrative

Photo evaluation: 1 photo was received for investigation (refer to attachment a).The photo was only showing the batch information on the unit package top web without showing the defective device.The photo received was showing batch # 3111826 and unreported material # 386811, which belongs to 20g gauge size.The reported material # is 386808, which is a 18g gauge size.However, the device was not shown in the photo, hence unable to evaluate if there is damage on adapter or catheter tubing which could potentially cause leakage.Batch number is unavailable and hence unable to perform the dhr review of the affected batch.Current control there is a daily outgoing leakage functional test that can detect catheter leakage caused by adapter luer or catheter tubing damage.There is also 2 hourly in-process visual inspection to check for catheter adapter and tubing damage.As no sample is returned for evaluation, actual root cause could not be established.

• Brand Name: CATHENA 18GX1.25IN WINGED BC
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore NJ 07417
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18051929
• MDR Text Key: 327271137
• Report Number: 2243072-2023-01980
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K172506
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/08/2023

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: 386808
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/13/2023
• Initial Date FDA Received: 11/01/2023
• Supplement Dates Manufacturer Received: 12/08/2023
• Supplement Dates FDA Received: 12/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other