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

Catalog Number	386811
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/30/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd cathena 20gx1.25in winged bc adapter / connector defective / damaged multiguard defect ¿once the catheter has been inserted into the vein.Plastic part of the non-return valve removed when the canula was removed.Catheter unusable with valve closed¿.The defective medical device has been returned to the pharmacy, and is available for return to the laboratory by courier.How do you wish to proceed with the return to the laboratory? when did the incident occur? unknown.
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
Multiguard defect ¿once the catheter has been inserted into the vein.Plastic part of the non-return valve removed when the canula was removed.Catheter unusable with valve closed¿.The defective medical device has been returned to the pharmacy, and is available for return to the laboratory by courier.How do you wish to proceed with the return to the laboratory? when did the incident occur? unknown.
Additional Manufacturer Narrative
Our the reported issue of adapter/ connector defective/ damaged was confirmed upon inspection of the sample.Analysis of the sample showed the actuator detached from the catheter adapter.The actuator was cracked at the molding gate.A review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately.Production records were reviewed, and this batch meets our manufacturing specification requirements.The assembly process was reviewed.The obstructed flow experienced by the user was caused by the detachment of the actuator from catheter adapter, which was caused by the crack observed.It was suspected that the crack at the molding gate occurred before the assembly process, which could have been during the actuator molding process at bd sandy plant.The bd sandy molding team was notified of this complaint.

• 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: 19589249
• Report Number: 2243072-2024-00741
• Device Sequence Number: 7279015
• Product Code: FOZ
• UDI-Device Identifier: 00382903868117
• UDI-Public: (01)00382903868117
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K220584
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2024

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: 386811
• Device Lot Number: 4005487
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2024
• Supplement Date Received by Manufacturer: 08/14/2024
• Initial Report FDA Received Date: 06/21/2024
• Supplement Report FDA Received Date: 08/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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