MAUDE Adverse Event Report: BECTON DICKINSON BD CATHENA 20GX1.25IN WINGED BC; INTRAVASCULAR CATHETER

Catalog Number 386811

Device Problems Leak/Splash (1354); Migration or Expulsion of Device (1395); Defective Component (2292)

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

Event Date 10/11/2023

Event Type  Injury  

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.

Event Description

It was reported that bd cathena 20gx1.25in winged bc catheter backed out of vein the following information was provided by the initial reporter; pivc go out the vein after contrast injection (scanner) - permeability is ok before the exam after use consequences: extravasation of contrast medium.In some cases, radiology has been performed to visualize the extravasation.

Manufacturer Narrative

Based on device history record review, no abnormality was observed during the production of the potential affected batches.Current control there is a daily outgoing and 2-hourly in-process visual inspection to detect catheter tubing and adapter damage, and daily outgoing visual inspection to detect cannula damage.There is also a daily outgoing functional test on cannula and catheter penetration force to detect cannula and catheter tip damage.As no sample is returned for evaluation, actual root cause could not be established.

Event Description

Pivc go out the vein after contrast injection (scanner) - permeability is ok before the exam after use consequences: extravasation of contrast medium.In some cases, radiology has been performed to visualize the extravasation.

Manufacturer Narrative

Based on device history record review, no abnormality was observed during the production of the potential affected batches.Current control there is a daily outgoing and 2-hourly in-process visual inspection to detect catheter tubing and adapter damage, and daily outgoing visual inspection to detect cannula damage.There is also a daily outgoing functional test on cannula and catheter penetration force to detect cannula and catheter tip damage.As no sample is returned for evaluation, actual root cause could not be established.H3 other text: see h10 manufacture narrative.

Event Description

Pivc go out the vein after contrast injection (scanner) - permeability is ok before the exam.After use: consequences: extravasation of contrast medium.In some cases, radiology has been performed to visualize the extravasation.

• Brand Name: BD CATHENA 20GX1.25IN 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: 18041795
• MDR Text Key: 327023711
• Report Number: 2243072-2023-01974
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903868117
• UDI-Public: (01)00382903868117
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K220584
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 386811
• Device Lot Number: 3111826
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/28/2023
• 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