MAUDE Adverse Event Report: BECTON DICKINSON BD CATHENA 18GX2.00IN WINGED BC; INTRAVASCULAR CATHETER

Catalog Number	386809
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/06/2024
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 18gx2.00in winged bc safety shield activation failure (catheter) the needle safety guard did not activate.That is, after the injection, the tip of the needle was exposed and the protection remained attached to the body of the needle, i.E.In its original position.It also seems that the needle was not completely in the blade, as it felt like the patient had such impossibly thick skin, when the needle did not want to go through the skin.However, cannulation succeeded and the cannula itself worked.During use.The needle safety guard did not activate.
Additional Manufacturer Narrative
Based on device history record review, no abnormality was observed during the production of the affected batch.As current control, there are outgoing functional test and 2-hourly in-process functional test to check and detect safety activation failure.As no photo and sample is returned for evaluation, root cause could not be established.
Event or Problem Description
The needle safety guard did not activate.That is, after the injection, the tip of the needle was exposed and the protection remained attached to the body of the needle, i.E.In its original position.It also seems that the needle was not completely in the blade, as it felt like the patient had such impossibly thick skin, when the needle did not want to go through the skin.However, cannulation succeeded and the cannula itself worked.During use.The needle safety guard did not activate.

• Brand Name: BD CATHENA 18GX2.00IN 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: 19657555
• Report Number: 2243072-2024-00770
• Device Sequence Number: 20519496
• Product Code: FOZ
• UDI-Device Identifier: 00382903868094
• UDI-Public: (01)00382903868094
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• 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): 07/12/2024

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 Expiration Date: 08/31/2025
• Device Catalogue Number: 386809
• Device Lot Number: 2252683
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2024
• Supplement Date Received by Manufacturer: 07/12/2024
• Initial Report FDA Received Date: 07/02/2024
• Supplement Report FDA Received Date: 07/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/19/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown