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

Catalog Number 394900

Device Problem Loose or Intermittent Connection (1371)

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

Event Date 12/07/2022

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.

Event Description

It was reported while using bd connecta 3-way stopcock there was a bad connection.There was no report of patient impact.The following information was provided by the initial reporter, translated from japanese to english: this is a report about a loose stopcock tap.According to the customer's report, upon unpacking, the stopcock tap was loose in fitting/connectivity, and soon fell off.The user has experienced this several times this autumn and reported to bd this time.The user is wondering if this is a lot-to-lot variation issue or involves the other defect.

Event Description

It was reported while using bd connecta 3-way stopcock there was a bad connection.There was no report of patient impact.The following information was provided by the initial reporter, translated from japanese to english: this is a report about a loose stopcock tap.According to the customer's report, upon unpacking, the stopcock tap was loose in fitting/connectivity, and soon fell off.The user has experienced this several times this autumn and reported to bd this time.The user is wondering if this is a lot-to-lot variation issue or involves the other defect.

Manufacturer Narrative

H6: investigation summary since no photos or samples displaying the reported condition of loose component - no leak were available for examination, we were unable to fully investigate this incident.The device history records (dhr) review was performed for the lot number material identified in this complaint.According to the documented records, the product was manufactured according to the approved manufacturing procedures, specifications, and then released by quality assurance.H3 other text : see h10.

• Brand Name: BD CONNECTA 3-WAY STOPCOCK
• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 16056917
• MDR Text Key: 308459971
• Report Number: 9610847-2022-00504
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 01/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 394900
• Device Lot Number: 2003249
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/21/2022
• 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