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

Catalog Number 394945

Device Problem Leak/Splash (1354)

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

Event Date 10/09/2018

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.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 bd connecta¿ stopcock leaked.There was no report of exposure, injury, or medical intervention.

Event Description

It was reported that the bd connecta¿ stopcock leaked.There was no report of exposure, injury, or medical intervention.

Manufacturer Narrative

Investigation summary: a device history review was conducted for lot number 8149878 records show the reported lot was manufactured on 06/02/2018; it was determined that this is the only instance of leakage 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 of packaged goods.Additionally, the sample was subjected to leakage testing; allowing bd engineers to determine that the most likely root cause for this event is related to the tubing assembly process.Wearing down of the manufacturing machinery can result in a misalignment that can, under the right circumstances, result in a leaking device.To prevent similar occurrences, bd is currently reviewing the manufacturing line for possible optimization solutions.For leakage issue in leakage/air in injection valve that have been detected in others customer complaints, the team previously confirmed issues with this product lot 8037509 where leakage occurred at the valve port assy.Due to a bad tubing assembly.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 and process eura eurap2053001 were reviewed and there are proper controls in place to detect product malfunctions.Nogales will open a capa (#629955) not because of the cid as it is ¿no capa required¿ as per cpr-028 based on the severity and occurrence calculation, the reason to open the capa is to better support the exposure to external stakeholders, the focus of the capa will be batch 8037509 and sub-assembly lots related to that batch.

• 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: 8016886
• MDR Text Key: 125452303
• Report Number: 9610847-2018-00348
• 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: 11/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 04/30/2021
• Device Catalogue Number: 394945
• Device Lot Number: 8149878
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2018
• Date Manufacturer Received: 10/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other