MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD CONNECTA¿ MULTIFLO¿ 3-WAY MULTIPLE INFUSION MANIFOLD; IV SET STOPCOCK

Catalog Number 394601

Device Problem Leak/Splash (1354)

Patient Problems Cardiac Arrest (1762); Insufficient Information (4580)

Event Date 12/06/2021

Event Type  Injury  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 1158384.Medical device expiration date: 2024-05-31.Device manufacture date: 2021-06-30.Medical device lot #: unknown.Medical device expiration date: unknown.Device manufacture date: unknown.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 bd connecta¿ multiflo¿ 3-way multiple infusion manifold experienced two cases of tubing separation from device adapter, and two cases of leakage.The patient experienced cardiac arrest during device use.There was no mention of medical intervention, or final consequence to the patient.The following information was provided by the initial reporter: disconnection of the valves from each other.Taps on the central catheter: if the taps are tightened too much, risk of rupture of the luer-lock system with impossibility to use them again and risk of gas embolism cardiology patient blood reflux and leakage at the patient's head leads to the interruption of the sedation and the patient's awakening hypertensive crisis during the cpb.The heating blanket seems to cause a maladjustment by dilatation of the screw thread of the valve problem already encountered having led to cardiac arrest in another patient (two associated valves were maladjusted).

Manufacturer Narrative

The following information has been updated/corrected: b.5.Describe event or problem: it was reported that bd connecta¿ multiflo¿ 3-way multiple infusion manifold experienced a case of tubing separation from device adapter.The patient experienced cardiac arrest during device use.There was no mention of medical intervention, or final consequence to the patient.The following information was provided by the initial reporter: disconnection of the valve.The heating blanket seems to cause a maladjustment by dilation of the screw thread of the valve.Problem encountered led to cardiac arrest in patient (two associated valves were maladjusted).D.4.Medical device lot #: 1158384.D.4.Medical device expiration date: 2024-05-31.D.10.Device returned to manufacturer?: yes.D.10.Returned to manufacturer on: 2022-01-19.H.4.Device manufacture date: 2021-06-30.H.6.Investigation summary: our quality engineer inspected the 3 used samples submitted for evaluation.The reported issues were not confirmed upon inspection and testing of the samples.The samples were visually inspected, and no abnormalities or damages were observed.The samples were then functionally tested for leakage and disconnection using our own internal testing methods.During testing no signs of leakage were observed and no signs of disconnection were observed.Bd cannot determine a manufacturing related root cause since the defects were not confirmed.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 the lot numbers of the returned samples could not be confirmed.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.

Event Description

It was reported that bd connecta¿ multiflo¿ 3-way multiple infusion manifold experienced a case of tubing separation from device adapter.The patient experienced cardiac arrest during device use.There was no mention of medical intervention, or final consequence to the patient.The following information was provided by the initial reporter: disconnection of the valve.The heating blanket seems to cause a maladjustment by dilation of the screw thread of the valve.Problem encountered led to cardiac arrest in patient (two associated valves were maladjusted).

• Brand Name: BD CONNECTA¿ MULTIFLO¿ 3-WAY MULTIPLE INFUSION MANIFOLD
• Type of Device: IV 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13160031
• MDR Text Key: 285805295
• Report Number: 9610847-2021-00634
• Device Sequence Number: 1
• Product Code: FMG
• 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: 02/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 06/30/2021
• Device Catalogue Number: 394601
• Device Lot Number: 1158384
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2021
• 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
• Patient Outcome(s): Other