MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD CONNECTA¿ STOPCOCK; INTRAVASCULAR ADMINISTRATION SET

Catalog Number 394602

Device Problem Leak/Splash (1354)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 02/15/2022

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.Device manufacture date: unknown.A sample is available for evaluation.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported while using bd connecta¿ stopcock leakage occurred from the device.There was no report of patient impact.The following information was provided by the initial reporter: could you confirm whether the defect affected any patient? there was blood running from the central line but in the end it was not so much that the patient was adversely affected, fortunately.Leakage of three-way valve.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 23-mar-2022.H6: investigation summary: our quality engineer inspected the 1 sample submitted for evaluation.The reported issue was confirmed upon inspection and testing of the sample.During the evaluation the sample leaked during testing.Further inspection found breakage in the housing which caused the leakage.The damage observed is commonly caused by excessive force being applied to the product during use with a lubrication solution or infusion of high ph-value.It is recommended that prior to the use of bd products to review the instructions for use documentation supplied to ensure the greatest chances of there being no failures during use.A device history record review was not performed since no lot number was supplied.H3 other text : see h10.

Event Description

It was reported while using bd connecta¿ stopcock leakage occurred from the device.There was no report of patient impact.The following information was provided by the initial reporter: - could you confirm whether the defect affected any patient? there was blood running from the central line but in the end it was not so much that the patient was adversely affected, fortunately.Leakage of three-way valve.

• Brand Name: BD CONNECTA¿ STOPCOCK
• 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: 13674062
• MDR Text Key: 286957693
• Report Number: 9610847-2022-00088
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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: 04/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 394602
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1