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 Problem Leak/Splash (1354)

Patient Problems Air Embolism (1697); Hypoxia (1918)

Event Date 08/05/2020

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.(b)(4).

Event Description

It was reported that the bd connecta¿ multiflo¿ 3-way multiple infusion manifold connection to the patient's central venous line was loose and found detached from it during use.As a result, the patient received, "abrupt desaturation with a glasgow 3 coma for gas embolism," consisting of "orotracheal intubation, mechanical ventilation, sedation, transfer to resuscitation" and transferred to another establishment for "hyperbaric oxygenation." the following information was provided by the initial reporter, translated from (b)(6) to english: disconnection of a 3-way valve with the tubing of a patient's central venous line.The median lumen of the central line is left out in the open.The tap and the adjoining tubing are found to be totally disconnected when they were previously in place, with dry compresses and no liquid on the patient.This resulted in abrupt desaturation with a glasgow 3 coma for gas embolism.The treatment consisted of orotracheal intubation, mechanical ventilation, sedation, transfer to resuscitation.Then in a second stage, transfer to another establishment for hyperbaric oxygenation.The situation has evolved favourably.The complete perfusion set-up was retained, but the central venous line, and tubing were discarded.

Event Description

It was reported that the bd connecta¿ multiflo¿ 3-way multiple infusion manifold connection to the patient's central venous line was loose and found detached from it during use.As a result, the patient received "abrupt desaturation with a glasgow 3 coma for gas embolism", consisting of "orotracheal intubation, mechanical ventilation, sedation, transfer to resuscitation" and transferred to another establishment for "hyperbaric oxygenation".The following information was provided by the initial reporter, translated from french to english: "disconnection of a 3-way valve with the tubing of a patient's central venous line.The median lumen of the central line is left out in the open.The tap and the adjoining tubing are found to be totally disconnected when they were previously in place, with dry compresses and no liquid on the patient.This resulted in abrupt desaturation with a glasgow 3 coma for gas embolism.The treatment consisted of orotracheal intubation, mechanical ventilation, sedation, transfer to resuscitation.Then in a second stage, transfer to another establishment for hyperbaric oxygenation.The situation has evolved favourably.The complete perfusion set-up was retained, but the central venous line and tubing were discarded.".

Manufacturer Narrative

The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 12/22/2020.H.6.Investigation: a device history record review was completed for provided lot number 0004285.The review did not reveal any detected abnormalities during the production process that could have contributed to this defect and all quality tests were found to be within specification.To aid in the investigation of this issue, samples were returned for evaluation by our quality engineer team.The samples were functionally tested and inspected for signs of leakage; however, no negative results could be identified.Based on the investigation results, a cause related to the manufacturing process could not be determined for this reported incident.

• 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
• MDR Report Key: 10908243
• MDR Text Key: 218921753
• Report Number: 9610847-2020-00375
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 04/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 12/31/2022
• Device Catalogue Number: 394601
• Device Lot Number: 0004285
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2020
• Date Manufacturer Received: 04/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention