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

Catalog Number 394600

Device Problems Disconnection (1171); Leak/Splash (1354)

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

Event Date 02/01/2023

Event Type  malfunction  

Manufacturer Narrative

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 that the bd connecta¿ stopcock came loose and disconnected from the hub of the catheter, causing blood to leak out during use.The following information was provided by the initial reporter, translated from italian: "i have just received dr.Report for two accidents that occurred at the emergency surgery.The accident involved two taps with lot l2067587 expiring 02/2025 ref 394600.In both cases, the taps disconnected from the venous access causing significant blood loss to the patients.Update: accidents that occurred in the emergency surgery department.In both cases the stopcocks were connected to bd venflon pro safety cannula needles.During use they disconnected from the hub of the peripheral venous catheter causing massive blood loss to the patient.Death? no.Serious injury no.Erroneous results no.Course of treatment changed due to event? no.Exposure to blood/bodily fluid yes, blood leaking from the catheter hub.Medical int.Other than first aid yes, carrying out blood tests (complete blood count)".

Event Description

It was reported that the bd connecta¿ stopcock came loose and disconnected from the hub of the catheter, causing blood to leak out during use.The following information was provided by the initial reporter, translated from italian: "i have just received dr.Report for two accidents that occurred at the emergency surgery.The accident involved two taps with lot l2067587 expiring 02/2025 ref (b)(4).In both cases, the taps disconnected from the venous access causing significant blood loss to the patients.Update: accidents that occurred in the emergency surgery department.In both cases the stopcocks were connected to bd venflon pro safety cannula needles.During use they disconnected from the hub of the peripheral venous catheter causing massive blood loss to the patient.Death? -no serious injury - no erroneous results - no course of treatment changed due to event- no exposure to blood/bodily fluid - yes, blood leaking from the catheter hub medical int.Other than first aid - yes, carrying out blood tests (complete blood count).".

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 15-mar-2023 h6: investigation summary our quality engineer inspected the several samples submitted for evaluation.The reported issue of separation other component ¿ leak was not confirmed upon inspection and testing of the samples.Analysis of 10 of the samples showed that showed that there were no abnormalities or damages on the samples.The connections of the 10 samples were tested and all functioned without the reported defect.Bd was unable to determine a root cause for the reported failure since the defect was not confirmed during the analysis of the samples.Production records were reviewed, and this batch met our manufacturing product specification requirements.H3 other text : see h10.

• Brand Name: BD CONNECTA¿ STOPCOCK
• Type of Device: 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: 16457847
• MDR Text Key: 310412956
• Report Number: 9610847-2023-00040
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 03/27/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: 394600
• Device Lot Number: 2067587
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/02/2023
• Initial Date FDA Received: 03/01/2023
• Supplement Dates Manufacturer Received: 03/27/2023
• Supplement Dates FDA Received: 04/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/28/2022
• 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