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

Catalog Number	386808
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Extravasation (1842)
Date of Event	10/13/2023
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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 or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 2243072-2023-01980
• Device Sequence Number: 20852340
• Product Code: FOZ
• UDI-Device Identifier: 00382903868087
• UDI-Public: (01)00382903868087
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K172506
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Other
• Device Expiration Date: 10/31/2025
• Device Catalogue Number: 386808
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/13/2023
• Supplement Date Received by Manufacturer: 12/08/2023
• Initial Report FDA Received Date: 11/01/2023
• Supplement Report FDA Received Date: 12/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown