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 Problem No Consequences Or Impact To Patient (2199)

Event Date 11/03/2020

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.(b)(4).

Event Description

It was reported that the bd connecta¿ multiflo¿ 3-way multiple infusion manifold connection to the infusion device "slipped" when installed.The following information was provided by the initial reporter, translated from (b)(6) to english: "in order to reduce the trauma during the opening of the venous access, when the patient used the infusion tee, the connection with the infusion device slipped when the infusion was installed according to the procedure.Therefore, a new transfusion with three pipe pass.The incident delayed the treatment of patients and increased medical costs.".

Manufacturer Narrative

Investigation summary: a device history record review was completed by our quality engineer team for provided lot number 9066647.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.As a sample was unavailable for return, a thorough sample investigation could not be completed.Based on the investigation results, an exact cause for this incident could not be identified.There are quality controls currently in place to detect this type of defect during the production process.Further action has not been determined necessary at this time.

Event Description

It was reported that the bd connecta¿ multiflo¿ 3-way multiple infusion manifold connection to the infusion device "slipped" when installed.The following information was provided by the initial reporter, translated from chinese to english: "in order to reduce the trauma during the opening of the venous access, when the patient used the infusion tee, the connection with the infusion device slipped when the infusion was installed according to the procedure.Therefore, a new transfusion with three pipe pass.The incident delayed the treatment of patients and increased medical costs.".

• 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: 10933065
• MDR Text Key: 226056589
• Report Number: 9610847-2020-00387
• 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,other,user facility
• Type of Report: Initial,Followup
• Report Date: 12/04/2020

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: Other
• Device Expiration Date: 02/28/2022
• Device Catalogue Number: 394601
• Device Lot Number: 9066647
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/06/2020
• Initial Date FDA Received: 12/02/2020
• Supplement Dates Manufacturer Received: 12/04/2020
• Supplement Dates FDA Received: 12/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1