MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD CONNECTA¿ STOPCOCK WITH VALVE & EXTENSION TUBING

Catalog Number 394971

Device Problem Leak/Splash (1354)

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

Event Date 11/10/2018

Event Type  malfunction  

Manufacturer Narrative

(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 a bd connecta¿ stopcock with valve & extension tubing was leaked during use.

Manufacturer Narrative

Investigation summary: quality records have been consulted for tracking and trending purposes and no issues like this are detected which means low occurrence.A photo was provided confirming the issue by the customer.Also five samples were received; 1 used sample and 4 unused.Two different failure mode were evaluated.Investigation conclusion: bd was able to duplicate and confirm the customer¿s indicated failure mode for injection valve leakage in the photo returned.This failure mode was detected in other customer complaints where leakage occurred at the valve port assembly 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.Bd was able to confirm the failure mode of leakage from a cracked housing based on sample evaluation.Observed a crack on housing component; however, we were not able to associate this crack to the manufacturing process.We will keep monitoring the manufacturing process and in case any emerging trend is detected, further actions will be taken if necessary.The samples were leak tested at 43 psi according to procedure.Root cause description: based on investigation results to date, root cause of injection valve leakage was associated to a bad tubing assembly by station 5 of equipment vh59, however, nogales site opened capa to perform an investigation.Based on investigation results to date, root cause of leakage from cracked housing for manufacturing process cannot be determined.Rationale: injection valve leakage: nogales will open a capa (# (b)(4)) not because of the requirement per procedure, based on the severity and occurrence calculation.The reason to open the capa is to better support a situation analysis already opened.Leakage from cracked housing: based on an evaluation of severity and frequency it was determined that no corrective action is required at this time.

Event Description

It was reported that a bd connecta¿ stopcock with valve & extension tubing was leaked during use.

• Brand Name: BD CONNECTA¿ STOPCOCK WITH VALVE & EXTENSION TUBING
• Type of Device: STOPCOCK
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales
• 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: 8134310
• MDR Text Key: 129462325
• Report Number: 9610847-2018-00418
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 06/30/2021
• Device Catalogue Number: 394971
• Device Lot Number: 8184941
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/19/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/30/2018
• 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