MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD CONNECTA¿ STOPCOCK 3-WAY

Catalog Number 395000

Device Problem Device Markings/Labelling Problem (2911)

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

Event Date 03/09/2023

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 that 100 bd connecta¿ stopcock 3-way experienced incorrect label information.The following information was provided by the initial reporter: received phone call from customer (distributor) said the cat.No.395000, bd connecta instead of three waystopcock it's mentioned as four-way stopcock without extension tube mentioned in the package label.

Event Description

It was reported that 100 bd connecta¿ stopcock 3-way experienced incorrect label information.The following information was provided by the initial reporter: received phone call from customer (distributor) said the cat.No.395000, bd connecta instead of three waystopcock it's mentioned as four-way stopcock without extension tube mentioned in the package label.

Manufacturer Narrative

H6: investigation summary: our quality engineer inspected the 2 photos submitted for evaluation.The reported issue of documentation error-label content incorrect was confirmed upon inspection of the sample photos.Analysis of the sample photos showed that the documentation referred to the product as a 4-way stopcock, when the physical product was confirmed to be a 3-way stopcock.Bd determined that the cause of the failure was associated to our manufacturing process, and we are currently working on a project to solve the reported defect from recurring.Production records were reviewed, and this batch meets our manufacturing specification requirements.

• Brand Name: BD CONNECTA¿ STOPCOCK 3-WAY
• Type of Device: STOPCOCK
• 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: phillip emmert ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 16622454
• MDR Text Key: 312415115
• Report Number: 9610847-2023-00069
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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
• Report Date: 04/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 395000
• Device Lot Number: 2067626
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/11/2022
• 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