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 08/21/2020

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 plug was damaged, and couldn't be connected to the infusion tube before use.The following information was provided by the initial reporter, translated from (b)(6) to english, "before the operation, the connecta needed to be used to increase the intravenous access to the general anesthesia induction drug.When the connecta waas connected, it is found that the elastic plug was faulty and the infusion tube cannot be connected.Replaced the connecta immediately and give the drug in time.".

Manufacturer Narrative

H6: investigation summary: a device history record review was completed by our quality engineer team for provided lot number 9088783.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.H3 other text : see h.10.

Event Description

It was reported that the bd connecta¿ multiflo¿ 3-way multiple infusion manifold plug was damaged and couldn't be connected to the infusion tube before use.The following information was provided by the initial reporter, translated from chinese to english: "before the operation, the connecta needed to be used to increase the intravenous access to the general anesthesia induction drug.When the connecta waas connected, it is found that the elastic plug was faulty and the infusion tube cannot be connected.Replaced the connecta immediately and give the drug in time.".

• 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: 10646385
• MDR Text Key: 214171453
• Report Number: 9610847-2020-00315
• 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: 11/24/2020

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: 9088783
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/16/2020
• Initial Date FDA Received: 10/07/2020
• Supplement Dates Manufacturer Received: 11/23/2020
• Supplement Dates FDA Received: 11/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other