MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM; INTRAVASCULAR CATHETER

Catalog Number	383312
Medical Device Problem Codes	Break (1069); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/24/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that the bd saf-t-intima¿ iv catheter safety system leaked blood from the broken extension tubing during use.This occurred with 5 catheters.The following information was provided by the initial reporter, translated from chinese: "the ent nurse performed an indwelling needle for the patient on (b)(6) 2023.After catheter maintenance, he closed the tube sealing clip and found that the catheter extension tube was leaking blood.Careful observation revealed that the extension tube at the sealing clip was broken.This kind of situation has happened many times.".
Event or Problem Description
It was reported that the bd saf-t-intima¿ iv catheter safety system leaked blood from the broken extension tubing during use.This occurred with 5 catheters.The following information was provided by the initial reporter, translated from chinese: "the ent nurse performed an indwelling needle for the patient on (b)(6) 2023.After catheter maintenance, he closed the tube sealing clip and found that the catheter extension tube was leaking blood.Careful observation revealed that the extension tube at the sealing clip was broken.This kind of situation has happened many times.".
Additional Manufacturer Narrative
H6: investigation summary: our quality engineer inspected the 2 photos submitted for evaluation.The reported issue of tubing defective / damaged was confirmed upon inspection of the photo.The sample photo showed that the tubing of the catheter was damaged and leaking.However, bd cannot confirm the cause of the failure to our manufacturing process since no sample was returned for evaluation.Dhr was reviewed and no qns or other events were found related to the complaint stated by the customer.According to sampling plan applied for product performance, this lot was accepted.

• Brand Name: BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer (Section G): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• Manufacturer Contact: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17733196
• Report Number: 1710034-2023-01048
• Device Sequence Number: 6440819
• Product Code: FOZ
• UDI-Device Identifier: 00382903833122
• UDI-Public: 00382903833122
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K013800
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/19/2023

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: 03/31/2026
• Device Catalogue Number: 383312
• Device Lot Number: 2089814
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/24/2023
• Supplement Date Received by Manufacturer: 09/19/2023
• Initial Report FDA Received Date: 09/12/2023
• Supplement Report FDA Received Date: 10/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/02/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown