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

Catalog Number 394602

Device Problem Leak/Splash (1354)

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

Event Date 10/18/2021

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 that 2 bd connecta¿ stopcocks experienced leakage.The following information was provided by the initial reporter: the anesthesia department has determined that when using the 3-way-stopcok, propofol leaks drop by drop, it does not matter how tight the connection is.It happens with other fluids as well, but because propofol is kind of milky it is also more noticeable.Moreover, the same issue was experienced twice when two 3-way-stopcoks were connected to each other.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval? yes.D10: returned to manufacturer on: 2022-02-08.D4: medical device lot #: 1063368.D4: medical device expiration date: 2021-04-16.H4: device manufacture date: 2024-02-29.H6: investigation summary: our quality engineer inspected the 2 used samples submitted for evaluation.The reported issue was confirmed upon inspection and leakage testing of the samples.Of the two samples one was found to have leakage during testing.Further observation of the defective sample showed a raised surface on the a port.Bd determined that the cause of the failure was related to the molding process during production.It was determined that the raised surface was directly related to a specific molding station.Previous investigations found that other devices produced in the same mold also had the same leakage failure.As a preventative action the mold was determined to be defective and was replaced to prevent further reoccurrence.A device history record review could not be performed since a valid lot number was not reported or could be determined.The device history records (dhr) review was performed for the lot number 1063368.According to the documented records, the product was manufactured according to the approved manufacturing procedures, specifications, and then released by quality assurance.There were no nonconformance(s).

Event Description

It was reported that 2 bd connecta¿ stopcocks experienced leakage.The following information was provided by the initial reporter: the anesthesia department has determined that when using the 3-way-stopcock, propofol leaks drop by drop, it does not matter how tight the connection is.It happens with other fluids as well, but because propofol is kind of milky it is also more noticeable.Moreover, the same issue was experienced twice when two 3-way-stopcoks were connected to each other.

• Brand Name: BD CONNECTA¿ STOPCOCK
• 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12823979
• MDR Text Key: 284970099
• Report Number: 9610847-2021-00553
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 03/02/2022

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 Expiration Date: 02/29/2024
• Device Catalogue Number: 394602
• Device Lot Number: 1063368
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/19/2021
• Initial Date FDA Received: 11/16/2021
• Supplement Dates Manufacturer Received: 03/02/2022
• Supplement Dates FDA Received: 03/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/16/2021
• 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