MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD STOPCOCK 3 WAY WITH 10CM EXTENTION TUBING; INTRAVASCULAR ADMINISTRATION SET

Catalog Number 394995

Device Problem Deformation Due to Compressive Stress (2889)

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

Event Date 06/02/2022

Event Type  malfunction  

Event Description

It was reported while using bd stopcock 3 way with 10cm extention tubing the tubing expanded.There was no report of patient impact.The following information was provided by the initial reporter: swelling of the connector during injection of the contrast medium.Injection at 2cc/s on an implantable chamber.

Manufacturer Narrative

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

Manufacturer Narrative

H.6.Investigation summary: our quality engineer inspected the 1 used sample submitted for evaluation.The reported issue of bulge/ balloon in silicone segment / pump segment was not confirmed upon inspection and testing of the samples.During the examination, no damages were observed on the sample and during functional testing the sample worked properly.A manufacturing related root cause could not be determined since the defect was not confirmed.A review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately.

Event Description

It was reported while using bd stopcock 3 way with 10cm extension tubing the tubing expanded.There was no report of patient impact.The following information was provided by the initial reporter: swelling of the connector during injection of the contrast medium.Injection at 2cc/s on an implantable chamber.

• Brand Name: BD STOPCOCK 3 WAY WITH 10CM EXTENTION TUBING
• Type of Device: INTRAVASCULAR ADMINISTRATION 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: 14940161
• MDR Text Key: 303245890
• Report Number: 9610847-2022-00250
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 09/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 394995
• Device Lot Number: 2005355
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/28/2022
• 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