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

Catalog Number 394995

Device Problem Leak/Splash (1354)

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

Event Date 10/19/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported bd connecta¿ plus stopcock had issues with leakage.The following information was provided by the initial reporter, translated from (b)(6): ¿i have received additional worrisome reports from the surgical center about different wards experiencing leakages as well, so that all clinics of the whole university hospital are now affected by this.¿.

Manufacturer Narrative

The following fields were updated due to additional information: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 12/2/2021.H.6.Investigation: our quality engineer inspected the 5 samples from mat 394995, lot 1120585 submitted for evaluation.The reported issue was not confirmed upon inspection and testing of the samples.During inspection there were no abnormal conditions or damages on the returned samples.The samples also underwent our internal leakage testing and during testing, none of the 5 samples showed any leakage.Bd cannot confirm a manufacturing root cause of the defect since the defect was not confirmed during sample examination and testing.A device history record review showed no non-conformances associated with this issue during the production of this batch.

Event Description

It was reported bd connecta¿ plus stopcock had issues with leakage.The following information was provided by the initial reporter, translated from german: ¿i have received additional worrisome reports from the surgical center about different wards experiencing leakages as well, so that all clinics of the whole university hospital are now affected by this.¿.

• Brand Name: BD CONNECTA¿ PLUS STOPCOCK
• Type of Device: I.V. SET 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12823879
• MDR Text Key: 282564764
• Report Number: 9610847-2021-00552
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 01/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2024
• Device Catalogue Number: 394995
• Device Lot Number: 1120585
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/17/2021
• 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