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

Catalog Number	394910
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device expiration date: unknown.Device manufacture date: unknown.
Event or Problem Description
It was reported that the bd connecta¿ stopcock 3-way experienced leakage.The following information was provided by the initial reporter: this is a report about leakage with the use of 385433-zat.According to the customer¿s report, the fluid leaked from somewhere of the stopcock on 385433-zat.The drug used is inovan.
Additional Manufacturer Narrative
Investigation summary: our quality engineer inspected the 9 photos and 1 sample submitted for evaluation.The reported issue of leakage (leaks at connection to another set) was not confirmed upon inspection and testing of the samples.Analysis of the sample showed that there were no damages or defects present on the returned sample.The sample underwent leakage testing, and no leakage was observed during the testing.Bd could not determine a root cause for the failure since the reported defect was not confirmed during the sample evaluation.Production records were not reviewed since a batch number was not provided for the investigation.
Event or Problem Description
It was reported that the bd connecta¿ stopcock 3-way experienced leakage.The following information was provided by the initial reporter: this is a report about leakage with the use of 385433-zat.According to the customer¿s report, the fluid leaked from somewhere of the stopcock on 385433-zat.The drug used is inovan.

• Brand Name: BD CONNECTA¿ STOPCOCK 3-WAY
• Common Device Name: 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 ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 16624559
• Report Number: 9610847-2023-00071
• Device Sequence Number: 4457757
• Product Code: FMG
• UDI-Device Identifier: 00382903949106
• UDI-Public: (01)00382903949106
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/17/2023

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
• Operator of Device: Other
• Device Catalogue Number: 394910
• Device Lot Number: UKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/08/2023
• Supplement Date Received by Manufacturer: 05/17/2023
• Initial Report FDA Received Date: 03/27/2023
• Supplement Report FDA Received Date: 05/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown