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); Connection Problem (2900)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/16/2018

Event Type  malfunction  

Manufacturer Narrative

The date received by manufacturer has been used for this field.(b)(6).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 the male luer lock connection on the bd connecta¿ multiflo¿ 3-way multiple infusion manifold couldn't attach properly and had frequent disconnections from the cannula needle.There was no report of exposure, injury, or medical intervention noted.

Event Description

It was reported that the male luer lock connection on the bd connecta multiflo 3-way multiple infusion manifold couldn't attach properly and had frequent disconnections from the cannula needle.There was no report of exposure, injury, or medical intervention noted.

Manufacturer Narrative

Due to an it issue beginning on (b)(6) 2018, previously filed emdrs did not contain required fields.This supplemental emdr is filed to provide the following omitted fields: event attributed to: other.Device single use?: no.Device returned to manufacture: yes.The device history report for lot number 7335719 was reviewed, no related abnormalities were found.Material number (b)(4) for lot 7335719 was manufactured on 12-16-2017.This is the first instance of this failure mode with this lot number.According to the sampling plan applied for product performance, this lot was accepted and released, with no defects being noted during final assembly or in packaging visual inspections.Samples were provided for the purpose of aiding our quality engineer's investigation.Returned samples were visually identified for damage, subjected to leakage testing and subjected to separation force testing.The returned devices were found to be within product specification for all testing parameters.This specific product does not have a tubing component that is supplied by bd, preventing bd engineers from evaluating the returned devices for tubing separation from the y-adaptor.The root cause for this complaint could not be determined without the ability to observe or replicate the reported failure mode.Bd will continue to track and trend for this issue.

• 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
• MDR Report Key: 7749455
• MDR Text Key: 116393501
• Report Number: 9610847-2018-00237
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• 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: 09/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 11/30/2020
• Device Catalogue Number: 394601
• Device Lot Number: 7335719
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2018
• Initial Date Manufacturer Received: 07/16/2018
• Initial Date FDA Received: 08/03/2018
• Supplement Dates Manufacturer Received: 07/16/2018
• Supplement Dates FDA Received: 09/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other