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

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	07/23/2024
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.B3.The date received by manufacturer has been used for this field.
Event or Problem Description
It was reported that bd us cathena 20gx1.25in straight bc safety mechanism does not fully cover needle.It was reported by customer that white safety mechanism stuck in housing, didn't cover needle tip when catheter advanced.Verbatim: white safety mechanism stuck in housing, didn't cover needle tip when catheter advanced.
Event or Problem Description
Material # 386863; batch # 4082702.It was reported by customer that white safety mechanism stuck in housing, didn't cover needle tip when catheter advanced.Verbatim: white safety mechanism stuck in housing.Didn't cover needle tip when catheter advanced.
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 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.

• Brand Name: BD US CATHENA 20GX1.25IN STRAIGHT 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: 19973639
• Report Number: 2243072-2024-00893
• Device Sequence Number: 20601829
• Product Code: FOZ
• UDI-Device Identifier: 00382903868636
• UDI-Public: (01)00382903868636
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 08/20/2024

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: 4082702
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/23/2024
• Supplement Date Received by Manufacturer: 08/20/2024
• Initial Report FDA Received Date: 08/13/2024
• Supplement Report FDA Received Date: 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/03/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown