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

Catalog Number	386811
Medical Device Problem Codes	Leak/Splash (1354); Migration or Expulsion of Device (1395); Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/11/2023
Type of Reportable Event	Serious Injury
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.
Event or Problem 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.
Additional 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 or Problem 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.
Additional 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 or Problem 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
• 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: 18041795
• Report Number: 2243072-2023-01974
• Device Sequence Number: 12628971
• Product Code: FOZ
• UDI-Device Identifier: 00382903868117
• UDI-Public: (01)00382903868117
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K220584
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/02/2024

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
• Operator of Device: Other
• Device Expiration Date: 04/30/2026
• Device Catalogue Number: 386811
• Device Lot Number: 3111826
• 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: 10/10/2023
• Supplement Date Received by Manufacturer: 12/19/2023; 12/19/2023
• Initial Report FDA Received Date: 10/31/2023
• Supplement Report FDA Received Date: 12/21/2023; 01/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/28/2023
• 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