MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD® CONNECTA¿ STOPCOCK STAND-ALONE; STOPCOCK, IV SET

Catalog Number 394602

Device Problem Leak/Splash (1354)

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

Event Date 07/13/2022

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: since no photos or samples displaying the reported condition of leakage were available for examination, we were unable to fully investigate this incident.Examination of the product involved may provide clarification as to the cause for the reported failure.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.

Event Description

It was reported that while using bd® connecta¿ stopcock stand-alone there was a leakage of the contrast agent that would affect the accuracy of the inspection results.It will cause blood spurting, which will cause iatrogenic infection and increase the risk of occupational exposure of medical staff.The following information was provided by the initial reporter, translated from chinese to english: the patient came to the hospital for treatment on (b)(6) because of a headache.During the foaming test inspection according to the doctor's instructions, there was a leakage of the contrast agent in the three-way tube.The leakage of the contrast agent would affect the accuracy of the inspection results.It will cause blood spurting, which will cause iatrogenic infection and increase the risk of occupational exposure of medical staff.Since (b)(6) 2022, there have been many leakage incidents of this three-way tube.It hopes relevant departments will pay attention to it and urge production manufacturers to make timely improvements.

• Brand Name: BD® CONNECTA¿ STOPCOCK STAND-ALONE
• Type of Device: STOPCOCK, IV 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: 15211059
• MDR Text Key: 305285275
• Report Number: 9610847-2022-00298
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 394602
• Device Lot Number: 1215739
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2021
• 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