MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD CONNECTA¿ 3-WAY STOPCOCK; INTRAVASCULAR ADMINISTRATION SET

Catalog Number 394600

Device Problem Leak/Splash (1354)

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

Event Date 11/13/2022

Event Type  malfunction  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported while using bd connecta¿ 3-way stopcock leakage occurred.There was no report of patient impact.The following information was provided by the initial reporter: drip from the connections.While treating the patient, the female connection ran backwards and a leak formed between the connections.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 8-dec-2022.H6: investigation summary our quality engineer inspected the 1 sample submitted for evaluation.The reported issue of leakage was not confirmed upon inspection and testing of the sample.Analysis of the sample showed that the returned sample had no abnormalities or defects.The sample underwent leakage testing and was found to be compliant.Bd determined that the cause of the failure cannot be associated to the manufacturing process since the defect was not confirmed.The device history records (dhr) review was performed for the lot number material identified in this complaint.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.

Event Description

It was reported while using bd connecta¿ 3-way stopcock leakage occurred.There was no report of patient impact.The following information was provided by the initial reporter: drip from the connections.While treating the patient, the female connection ran backwards and a leak formed between the connections.

• Brand Name: BD CONNECTA¿ 3-WAY STOPCOCK
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• 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: 15934766
• MDR Text Key: 308088141
• Report Number: 9610847-2022-00459
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Reporter Country Code: IS
• 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: 01/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 394600
• Device Lot Number: 1279946A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/27/2021
• 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