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	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/30/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B.3.Date of event: unknown.The date received by manufacturer has been used for this field.H.3.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that during use with bd connecta¿ stopcock 3-way the product has a loose component.There was no report of patient impact.The following information was provided by the initial reporter, translated from japanese to english: this report about a loose needle cover.Since about a month ago, the needle cap of the side injection part of the stopcock has been loose and almost falling off.
Event or Problem Description
It was reported that during use with bd connecta¿ stopcock 3-way the product has a loose component.There was no report of patient impact.The following information was provided by the initial reporter, translated from japanese to english: this report about a loose needle cover.Since about a month ago, the needle cap of the side injection part of the stopcock has been loose and almost falling off.
Additional Manufacturer Narrative
H6: investigation summary our quality engineer inspected the 1 photo and 1 unused sample submitted for evaluation.The reported issue of loose component - no leak was not confirmed upon inspection of the samples.Analysis of the sample and photo showed that there was no defect or abnormality present on the sample.Bd could not determine a manufacturing related root cause since the reported defect was not confirmed during the evaluation of the sample.Production records were reviewed, and this batch meets our manufacturing specification requirements.H3 other text : see h10.

• 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 ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17183111
• Report Number: 9610847-2023-00151
• Device Sequence Number: 6391574
• 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): 07/06/2023

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 Expiration Date: 03/31/2025
• Device Catalogue Number: 394910
• Device Lot Number: 2095782
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2023
• Supplement Date Received by Manufacturer: 07/06/2023
• Initial Report FDA Received Date: 06/22/2023
• Supplement Report FDA Received Date: 07/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/06/2022
• 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