MAUDE Adverse Event Report: BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. BD CONNECTA¿ STOPCOCKS CONNECTA PLUS 3 7 CM WHITE BLEND

Catalog Number 394945

Device Problem Leak/Splash (1354)

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

Event Date 10/19/2017

Event Type  malfunction  

Manufacturer Narrative

Investigation summary bd was not able to duplicate or confirm the customer¿s indicated failure mode.Customer reported leakage issues; however no sample was available for evaluation which is essential to perform a better investigation.Investigation conclusion bd was not able to duplicate or confirm the customer¿s indicated failure mode.Customer reported leakage issues; however no sample was available for evaluation which is essential to perform a better investigation.Quality records have been consulted for tracking and trending purposes and no issues like this are detected which means pretty low occurrence.Product is functional tested and no incidents with leakages have been reported.Process fmea (b)(4) was reviewed and there are proper controls in place to detect product malfunctions.Always refer to ifu for product usage recommendations.We will keep monitoring the manufacturing process and in case any emerging trend is detected, further actions will be taken if necessary.Root cause description based on investigation results to date, root cause for manufacturing process cannot be determined.Dhr - material (b)(4) with lot number 7152548 was manufactured on jun-29-2017 by equipment (b)(4).No qn's or other extraordinary events that can explain the incident have been related.Manufacturing review- no issues detected from manufacturing process, maintenance or calibrated instruments.

Event Description

It was reported that a bd connecta¿ stopcocks connecta plus 3 7 cm white blend malfunctioned during use as the connection between the extension tube and three way stop cock was found to be leaking.There was no report of injury or medical intervention needed.

Manufacturer Narrative

Investigation results: three samples were received for evaluation.Leak testing was performed on each unit and no leakage was observed.We were unable to determine a root cause for this event based on the provided samples as bd was not able to duplicate or confirm the customer¿s indicated failure mode.Dhr review shows material 394945 with lot number 7152548 was manufactured on jun-29-2017 by equipment ka56.No qn's or other extraordinary events that can explain the incident have been related.Quality records have been consulted for tracking and trending purposes and no issues like this are detected.Process fmea rm5943 was reviewed and there are proper controls in place to detect product malfunctions.Conclusion: based on investigation results to date, root cause for manufacturing process cannot be determined.Based on an evaluation of severity and frequency it was determined that no corrective action is required at this time.We will keep monitoring the manufacturing process and in case any emerging trend is detected, further actions will be taken if necessary.

• Brand Name: BD CONNECTA¿ STOPCOCKS CONNECTA PLUS 3 7 CM WHITE BLEND
• Type of Device: STOPCOCK
• Manufacturer (Section D): BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.; ave. pres.juscelino kubitschek; 273 francisco bernardino; juiz de fora
• Manufacturer (Section G): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 7026261
• MDR Text Key: 92923229
• Report Number: 9610847-2017-00142
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: K974083
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 05/31/2020
• Device Catalogue Number: 394945
• Device Lot Number: 7152548
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/20/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other