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 Information (3190)

Event Date 01/17/2019

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: customer reported injection valve leakage; this failure mode was detected in others customer complaints 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.A device history review was conducted for lot number 8250929.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.Bd will continue to monitor this issue.Investigation conclusion: bd was not able to confirm the customer¿s indicated failure mode because photo or samples were not provided.Root cause description: 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.Rationale: 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 a situation analysis opened.

Event Description

It was reported that the bd connecta¿ stopcock leaked from the injection port when the nurse attempted to administer the medication.

• 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
• 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 ; 8015652341
• MDR Report Key: 8302388
• MDR Text Key: 135359072
• Report Number: 9610847-2019-00121
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Reporter Country Code: SW
• 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
• Report Date: 01/18/2019

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: Health Professional
• Device Expiration Date: 08/31/2021
• Device Catalogue Number: 394945
• Device Lot Number: 8250929
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/17/2019
• Initial Date FDA Received: 02/04/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/10/2018
• 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