MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD 3 WAY STOPCOCK, LUER LOCK; INTRAVASCULAR ADMINISTRATION SET

Catalog Number 04301433200

Device Problem Inaccurate Information (4051)

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

Event Date 08/06/2021

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported when using the 3 way stopcock, luer lock , the device experienced incorrect label information.This event occurred 300 times.The following information was provided by the initial reporter.The customer stated: hospital received the product as a substitute for the back order smartsite stopcock which is unavailable.Product description and content product is a 3 way stopcock however packaging description states it's a 4 way.

Event Description

It was reported when using the3 way stopcock, luer lock , the device experienced incorrect label information.This event occurred 300 times.The following information was provided by the initial reporter.The customer stated: hospital received the product as a substitute for the back order smartsite stopcock which is unavailable.Product description and content product is a 3 way stopcock however packaging description states it's a 4 way as seen in pictures attached.

Manufacturer Narrative

H6: investigation summary: no samples were required for investigation of complaint in which the customer has reported a labelling anomaly whereby the 04301433200 product is labelled as a '4-way' stopcock on the packaging.The customer also provided a photograph of the affected packaging.A device history review was conducted for lot number 562313.The 04301433200 product is considered to be a '4-way' tap because the blue tap component can be rotated 360 degrees and therefore, depending on the clinical requirements of the product at the time of use, the component can be set to four different infusion positions.A review of the customer feedback database indicates that this is an isolated feedback with no further reports of this nature against the 04301433200 product in the past 24 months; based on the current level of feedback there is no immediate intention to change the naming convention to indicate the number of tubing outlets rather than the number of potential tap positions.H3 other text : see h10.

Manufacturer Narrative

Correction: after further evaluation of the complaint, it has been determined that the previously submitted mfr report# 9610847-2021-00420 was sent in error.Mfr report# 9610847-2021-00420 is void as a result.

Event Description

It was reported when using the 3 way stopcock, luer lock , the device experienced incorrect label information.This event occurred 300 times.The following information was provided by the initial reporter.The customer stated: hospital received the product as a substitute for the back order smartsite stopcock which is unavailable.Product description and content product is a 3 way stopcock however packaging description states it's a 4 way as seen in pictures attached.

• Brand Name: BD 3 WAY STOPCOCK, LUER LOCK
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12425644
• MDR Text Key: 271327896
• Report Number: 9610847-2021-00420
• Device Sequence Number: 1
• Product Code: ONB
• UDI-Device Identifier: 04301433200
• UDI-Public: 04301433200
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/02/2022

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: Other
• Device Catalogue Number: 04301433200
• Device Lot Number: 562313
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/06/2021
• Initial Date FDA Received: 09/03/2021
• Supplement Dates Manufacturer Received: 09/16/2021; 09/16/2021
• Supplement Dates FDA Received: 09/28/2021; 08/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/09/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1