MAUDE Adverse Event Report: BECTON DICKINSON BD CATHENA 22GX1.00IN WINGED BC; INTRAVASCULAR CATHETER

Catalog Number	386813
Medical Device Problem Code	Partial Blockage (1065)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/07/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
It was reported that bd cathena 22gx1.00in winged bc needle clogged / blocked impossible to draw blood out of the catheter 22g impossible to draw blood out of the catheter hub in using vacutianer tube.By the way, there is no issue to inject something in using the catheter hub.Is that due to the multiguard valve and the force which is reduced by vacutainer tube? when did the incident occur? during use.
Event or Problem Description
Impossible to draw blood out of the catheter 22g.Impossible to draw blood out of the catheter hub in using vacutianer tube.By the way, there is no issue to inject something in using the catheter hub.Is that due to the multiguard valve and the force which is reduced by vacutainer tube? when did the incident occur? during use.
Additional Manufacturer Narrative
Based on device history record review, no abnormality was observed during the production of the affected batches.As current control, there is a needle flashback functional test performed during routine outgoing inspection to check for needle occlusion.As no photo/sample is returned for evaluation, actual root cause could not be established.The complaint will be re-opened and re-investigated when photo/sample is received.
Event or Problem Description
Impossible to draw blood out of the catheter 22g.Impossible to draw blood out of the catheter hub in using vacutianer tube.By the way, there is no issue to inject something in using the catheter hub.Is that due to the multiguard valve and the force which is reduced by vacutainer tube? when did the incident occur? during use.
Additional Manufacturer Narrative
Based on device history record review, no abnormality was observed during the production of the affected batches.As current control, there is a needle flashback functional test performed during routine outgoing inspection to check for needle occlusion.As no photo/sample is returned for evaluation, actual root cause could not be established.The complaint will be re-opened and re-investigated when photo/sample is received.
Additional Manufacturer Narrative
Becton dickinson and company's (bd) medication delivery solutions (mds) business unit will discontinue malfunction mdr reporting for certain device failures that have not caused or contributed to deaths or serious injuries in the past two years, and where the likelihood of a death or serious injury as a result of these malfunctions is remote.This decision follows fda guidelines (medical device reporting for manufacturers guidance for industry and food and drug administration staff issued nov 8, 2016, reference section 2.15).Bd notified fda of this decision on mar 3, 2025.Fda has reviewed and responded to bd¿s notification (reference fda document # (b)(4)) on march 7, 2025.This documentation is available in bd document management system (sap) as dir (b)(4).This supplemental mdr is being filed to document that the below device failure will no longer be considered a reportable malfunction mdr for the product family below: product family: cathena.Device failure: needle clogged/blocked.
Event or Problem Description
No additional information.

• Brand Name: BD CATHENA 22GX1.00IN 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: 19424950
• Report Number: 2243072-2024-00664
• Device Sequence Number: 12767089
• Product Code: FOZ
• UDI-Device Identifier: 00382903868131
• UDI-Public: (01)00382903868131(11)240108(17)261231(10)3362028
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K172506
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/30/2025

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
• Operator of Device: Health Professional
• Device Catalogue Number: 386813
• Device Lot Number: 3362028
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/07/2024
• Supplement Date Received by Manufacturer: 06/06/2024; 09/19/2024; Not provided
• Initial Report FDA Received Date: 05/30/2024
• Supplement Report FDA Received Date: 06/07/2024; 09/20/2024; 04/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/08/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown