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

Catalog Number 394600

Device Problem Loose or Intermittent Connection (1371)

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

Event Date 12/21/2022

Event Type  malfunction  

Event Description

It was reported that the bd connecta¿ stopcock disconnected from the ebus bronchoscope when trying to tighten it.The following information was provided by the initial reporter: "they attach the connecta to a ebus bronchoscope (olympus bf-uc190f and bf-uc180f) and even when trying to tighten the connecta extra tight they experience that the connecta disconnects unintentionally.It happens 50% of the times they use it.They never had any issues with the stopcock they used before (unknown brand).No harm to patient or staff.".

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 disconnected from the ebus bronchoscope when trying to tighten it.The following information was provided by the initial reporter: "they attach the connecta to a ebus bronchoscope (olympus bf-uc190f and bf-uc180f) and even when trying to tighten the connecta extra tight they experience that the connecta disconnects unintentionally.It happens 50% of the times they use it.They never had any issues with the stopcock they used before (unknown brand).No harm to patient or staff.".

Manufacturer Narrative

H6: investigation summary: it was reported the connecta disconnects from an ebus bronchoscope.To aid in the investigation, photos were provided for evaluation by our quality team.In the photos, no problems are observed with the device.Bd recommends using the method provided in the instruction manual.A device history record review was completed for provided material number 394600, lot 2067587b.According to the documented records, the product was manufactured according to the approved manufacturing procedures, specifications, and then released by quality assurance.

• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 16550310
• MDR Text Key: 311704255
• Report Number: 9610847-2023-00061
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Reporter Country Code: DA
• 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: 05/03/2023

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: 394600
• Device Lot Number: 2067587B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/21/2023
• Initial Date FDA Received: 03/15/2023
• Supplement Dates Manufacturer Received: 05/03/2023
• Supplement Dates FDA Received: 05/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/28/2022
• 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