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

Catalog Number 394600

Device Problem Loose or Intermittent Connection (1371)

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

Event Date 12/01/2022

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 the bd connecta¿ stopcock 3-way connection was loose and separated.The following information was provided by the initial reporter: we have had incidents lately with the material reference: 394600.The lots we are aware of are 2032403c.The 3-step stopcocks do not close properly and disconnect from the patient during surgery, stopping the infusion of the medication during general anaesthesia.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval: yes.D10: returned to manufacturer on: 11-jan-2023.H6: investigation summary: our quality engineer inspected the 1 sample submitted for evaluation.The reported issue of connection issues was not confirmed upon inspection of the sample.Analysis of the sample showed that there were no irregularities or damages on the connector.The connector was tested and there were no issues with the connection of the sample.Bd could not determine a manufacturing related root cause since the failure was not confirmed by the sample evaluation.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.

Event Description

It was reported that the bd connecta¿ stopcock 3-way connection was loose and separated.The following information was provided by the initial reporter: we have had incidents lately with the material reference: (b)(4).The lots we are aware of are 2032403c.The 3-step stopcocks do not close properly and disconnect from the patient during surgery, stopping the infusion of the medication during general anaesthesia.

• 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 ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 16036151
• MDR Text Key: 307937606
• Report Number: 9610847-2022-00498
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: 02/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 394600
• Device Lot Number: 2032403
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/18/2022
• 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