MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD SAF-T-INTIMA SAFETY SYSTEM WITH Y ADAPTER 24 GA 0.75 IN INTRAVASCULAR CATHETER

Model Number 383313

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Patient Involvement (2645)

Event Date 08/06/2020

Event Type  malfunction  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated, but is not complete. Upon completion, a supplemental report will be filed. (b)(4).

Event Description

It was reported that 51 bd saf-t-intima¿ safety system with y adapter 24 ga 0. 75 in had incorrect label content. The following information was provided by the initial reporter: "it was reported that: iv's were coming up expired when item is scanned however the packaging shows that it does not expire until 2024-01-31. Barcode: (b)(4). Per customer response: i currently have 51 in my possession without taking stock from the floor. These 51 all have the same lot and scan expired. How many samples would you need? event description per attached email states:the quality team looked into it. There is an error in the barcode. The barcode showed the expiration of 2020 instead of 2024; it is important to mention that the due date printed on the unit label is the correct as well as the due date printed on shipper and dispenser labels. The quality team will complete a thorough investigation. Questions/inquiries: complaint rationale: based on the information provided, our conclusion is that the device cited meets our criteria of a complaint. Appendix 1: complaint determination tree:(b)(4). Customer is requesting replacement and credit. ".

• Brand Name: BD SAF-T-INTIMA SAFETY SYSTEM WITH Y ADAPTER 24 GA 0.75 IN
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• Manufacturer (Section G): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652341
• MDR Report Key: 10457962
• MDR Text Key: 214379374
• Report Number: 9610847-2020-00262
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K013800
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 383313
• Device Catalogue Number: 383313
• Device Lot Number: 0035306
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2020
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 08/07/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/14/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 08/26/2020 Patient Sequence Number: 1