MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD CONNECTA¿ STOPCOCK

Catalog Number 394945

Device Problem Fluid/Blood Leak (1250)

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

Event Date 11/23/2018

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.Additional contact e-mail: (b)(6).Device manufacture date: unknown.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 bd connecta¿ stopcock were leaked during use.

Event Description

It was reported that bd connecta¿ stopcock were leaked during use.

Event Description

It was reported that bd connecta¿ stopcock were leaked during use.

Manufacturer Narrative

Investigation summary: a lot number could not be submitted for this complaint, and could not be determined from the photographs provided.Preventing our investigation team from conducting a device history review.The sample submitted allowed our engineers to conduct leakage testing on the device, and determine that the leakage was originating from the injection valve.A subsequent review of our manufacturing line determined that the most likely root cause for this event is an abnormality in the equipment responsible for tubing assembly.To prevent a reoccurrence of this event we have retrained our personnel and optimized our manufacturing process to monitor this issue more thoroughly.Engineering team assessed the assembly process finding a worn pin in station 5 that could cause the reported failure mode.This pin is in charge of assembling the gray tubing into the valve housing.¿process fmea rm5943, rm5819 and process eura eurap2053001 were reviewed and there are proper controls in place to detect product malfunctions.Based on investigation results to date, for leakage issue (in injection valve) root cause was associated to a bad tubing assembly by station 5 of equipment vh59, however, nogales site opened capa to perform an investigation.

• Brand Name: BD CONNECTA¿ STOPCOCK
• 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: 8142569
• MDR Text Key: 129760350
• Report Number: 9610847-2018-00417
• 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,Followup
• Report Date: 02/01/2019

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 Catalogue Number: 394945
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2018
• Initial Date Manufacturer Received: 11/23/2018
• Initial Date FDA Received: 12/07/2018
• Supplement Dates Manufacturer Received: 11/23/2018; 11/23/2018
• Supplement Dates FDA Received: 01/28/2019; 02/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other