MAUDE Adverse Event Report: BD SUZHOU (MDS) BD US CATHENA 18GX1.25IN STRAIGHT BC; INTRAVASCULAR CATHETER

Catalog Number 386865

Device Problem Retraction Problem (1536)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/10/2023

Event Type  malfunction  

Manufacturer Narrative

H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.

Event Description

It was reported that bd us cathena 18gx1.25in straight bc needle retraction was slow it was reported by the customer that the needle did not totally retract into the safety chamber.Verbatim: rcc received a complaint via email.Email(s) attached.Bd cathena iv insertion catheter used to insert an iv in a patient.I had difficulty releasing the needle device from the canula because the needle did not totally retract into the safety chamber.The iv was functional after insertion so no harm to the patient but the iv insertion catheter had an exposed needle after use.

Manufacturer Narrative

Based on device history record review, no abnormality was observed during the production of the affected batches.Current control there is a routine outgoing functional test and 2 hourly in-process functional test to check and detect safety activation failure.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 Description

Material#: 386865 lot#: 2274711 it was reported by the customer that the needle did not totally retract into the safety chamber.Verbatim: rcc received a complaint via email.Email(s) attached.Bd cathena iv insertion catheter used to insert an iv in a patient.I had difficulty releasing the needle device from the canula because the needle did not totally retract into the safety chamber.The iv was functional after insertion so no harm to the patient but the iv insertion catheter had an exposed needle after use.Product: (b)(6).Lot: 2274711.

• Brand Name: BD US CATHENA 18GX1.25IN STRAIGHT BC
• Type of Device: INTRAVASCULAR CATHETER
• 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; singapore NJ 07417
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18651808
• MDR Text Key: 334676444
• Report Number: 2243072-2024-00123
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903868650
• UDI-Public: (01)00382903868650
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K220584
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/25/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 386865
• Device Lot Number: 2274711
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/18/2024
• Initial Date FDA Received: 02/06/2024
• Supplement Dates Manufacturer Received: 03/25/2024
• Supplement Dates FDA Received: 03/26/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/04/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1