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

Catalog Number 394601

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

Patient Problems Hemorrhage/Bleeding (1888); Insufficient Information (4580)

Event Date 09/20/2021

Event Type  Injury  

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 when using the bd connecta¿ multiflo¿ 3-way multiple infusion manifold, the device experienced a loose connection / separation which caused a leak.The following information was provided by the initial reporter.The customer stated: yesterday afternoon we met with the head of anaesthesia and intensive care, who quickly explained the dynamics of the accident as he was busy in the operating room: the tap was connected to a bd venflon pro safety cannula needle, the limb covered by a drape and out of sight.The tap had become disconnected from the cannula needle, resulting in significant blood loss and interruption of infusions.They only noticed the leak when the patient lost a considerable amount of blood as the drape placed under the patient absorbed the blood loss.He will shortly send a detailed report of the incident, which the pharmacy will forward to the health department and to us.The actions that will be immediately taken by the facility are the definitive suspension of the use of the connecta tap, which already has shown in other situations frequent leaks from the luer lock/needle cannula connection.I will replace the connecta with sendal taps (which they will evaluate) and with taps with extension which they suggested as the best solution.As soon as i have a copy of the report i will complete the information about the patient's condition and the connective actions taken on the patient.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 2021-11-01.H6: investigation summary: our quality engineer inspected the 3 packaged samples and 1 unpacked sample submitted for evaluation.The reported issue was not confirmed upon inspection and testing of the samples.During the visual examination of the samples no damages were observed on the samples.The 4 samples were also tested for leakage using our internal methods and none of the samples exhibited leakage.Since bd could not confirm the defect, a manufacturing root cause could not be determined.A device history record review showed no non-conformances associated with this issue during the production of this batch.A review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately.H3 other text : see h10.

Event Description

It was reported when using the bd connecta¿ multiflo¿ 3-way multiple infusion manifold, the device experienced a loose connection / separation which caused a leak.The following information was provided by the initial reporter.The customer stated: yesterday afternoon we met with the head of anaesthesia and intensive care, who quickly explained the dynamics of the accident as he was busy in the operating room: the tap was connected to a bd venflon pro safety cannula needle, the limb covered by a drape and out of sight.The tap had become disconnected from the cannula needle, resulting in significant blood loss and interruption of infusions.They only noticed the leak when the patient lost a considerable amount of blood as the drape placed under the patient absorbed the blood loss.He will shortly send a detailed report of the incident, which the pharmacy will forward to the health department and to us.The actions that will be immediately taken by the facility are the definitive suspension of the use of the connecta tap, which already has shown in other situations frequent leaks from the luer lock/needle cannula connection i will replace the connecta with sendal taps (which they will evaluate) and with taps with extension which they suggested as the best solution.As soon as i have a copy of the report i will complete the information about the patien's condition and the connective actions taken on the patient.

• Brand Name: BD CONNECTA¿ MULTIFLO¿ 3-WAY MULTIPLE INFUSION MANIFOLD
• 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12674927
• MDR Text Key: 277855362
• Report Number: 9610847-2021-00510
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 10/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2023
• Device Catalogue Number: 394601
• Device Lot Number: 0308755
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/27/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/08/2020
• 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