MAUDE Adverse Event Report: BD SUZHOU (MDS) BD US CATHENA 20GX1.25IN STRAIGHT BC; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	386863
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/08/2024
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 us cathena 20gx1.25in straight bc safety sheild activation failure.It was reported by customer that the cathena safety didn't activate.Verbatim: 18g 1.25" cathena safety didn't activate.
Additional Manufacturer Narrative
Based on device history record review, no abnormality was observed during the production of the affected batch.From the returned actual sample, no dent was observed on the cannula that would obstruct the movement of the tip shield for safety activation.There was also no damage to the v-clip and washer, which are key components for the safety mechanism activation.The safety mechanism of the returned sample was able to be manually activated; no safety activation failure was observed.As current control, there are outgoing functional test and in-process functional test to check and detect safety activation failure.
Event or Problem Description
Material #:386863 batch#:4160443.It was reported by customer that the cathena safety didn't activate.Verbatim: 18g 1.25" cathena safety didn't activate.

• Brand Name: BD US CATHENA 20GX1.25IN STRAIGHT BC
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BD SUZHOU (MDS); #5 baiyu road; suzhou industrial park; jiangsu 21502 1; CH 215021
• Manufacturer (Section G): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; suzhou industrial park; singapore 21502 1; CH 215021
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 20108734
• Report Number: 2243072-2024-00939
• Device Sequence Number: 7794761
• Product Code: FOZ
• UDI-Device Identifier: 00382903868636
• UDI-Public: (01)00382903868636(11)240608(17)270531(10)4160443
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K220584
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/10/2024

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: 386863
• Device Lot Number: 4160443
• 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: 08/09/2024
• Supplement Date Received by Manufacturer: 10/10/2024
• Initial Report FDA Received Date: 08/30/2024
• Supplement Report FDA Received Date: 10/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/08/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown