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 Material Protrusion/Extrusion (2979)

Patient Problem Blood Loss (2597)

Event Date 05/16/2019

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation and/or device history review, a supplemental report will be filed.

Event Description

It was reported that during use of the bd connecta¿ multiflo¿ 3-way multiple infusion manifold there was a failure to connect the tap which unscrews very quickly when patient moves, and has difficulty staying properly connected.When checking the infusion circuit at 0100 everything was fine, but at 0430 patient rang and blood was pooling on the floor and in the bed.Foreign complaint the following information was provided by the initial reporter, translated from french to english: customer reported that at 1:00 a.M., the whole infusion circuit was okay.At 4:30 am, patient ringing, blood pooling on the floor and in the bed failure to connect the tap which unscrews very quickly when patient moves, and has difficulty staying properly connected.This caused a backflow and a risk of contamination.So the circuit was changed, but the different valves tested all have this defect.

Manufacturer Narrative

H.6.Investigation summary: a device history review was conducted for lot number 7282513.Our records show that this is the only instance of this issue occurring in this production batch.According to the sampling plan applied for product performance, this lot was accepted and released without defects being noted during the final assembly or visual inspections.Unfortunately a sample could not be obtained for evaluation and testing.Without the ability to investigate the affected unit our quality engineers were unable to determine the root cause for this complaint.Based on investigation developed, the nogales team cannot confirm the reported defect because samples were no provided and the picture is not clear to perform a better evaluation and investigation.Quality records have been consulted for tracking and trending purposes and the results indicates no occurrence, the maintenance records no reveals any reported issues related to this issue during manufacturing date of the batch.

Event Description

It was reported that during use of the bd connecta¿ multiflo¿ 3-way multiple infusion manifold there was a failure to connect the tap which unscrews very quickly when patient moves, and has difficulty staying properly connected.When checking the infusion circuit at 0100 everything was fine, but at 0430 patient rang and blood was pooling on the floor and in the bed.Foreign complaint the following information was provided by the initial reporter, translated from french to english: customer reported that at 1:00 a.M., the whole infusion circuit was okay.At 4:30 am, patient ringing, blood pooling on the floor and in the bed -> failure to connect the tap which unscrews very quickly when patient moves, and has difficulty staying properly connected.This caused a backflow and a risk of contamination.So the circuit was changed, but the different valves tested - all have this defect.

• 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: 8675513
• MDR Text Key: 156500653
• Report Number: 9610847-2019-00405
• 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,other,user facility
• Type of Report: Initial,Followup
• Report Date: 08/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2020
• Device Catalogue Number: 394601
• Device Lot Number: 7282513
• Date Manufacturer Received: 05/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other