MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. CONNECTA PLUS3 7 CM WHITE BLEND; STOPCOCK

Catalog Number 394945

Device Problem Leak/Splash (1354)

Patient Problem No Information (3190)

Event Date 02/06/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 8086696.Medical device expiration date: 2021-02-28.Device manufacture date: 2018-05-09.Medical device lot #: 8117528.Medical device expiration date: 2021-03-31.Device manufacture date: 2018-06-06.Medical device lot #: 8149878.Medical device expiration date: 2021-04-30.Device manufacture date: 2018-07-19.Medical device lot #: 8151681.Medical device expiration date: 2021-04-30.Device manufacture date: 2018-08-08.Medical device lot #: 8226712.Medical device expiration date: 2021-07-31.Device manufacture date: 2018-09-24.Investigation summary: bd was able to confirm the customer¿s indicated failure mode in the received picture.Investigation conclusion: 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, rm5819 and process eura eurap2053001 were reviewed and there are proper controls in place to detect product malfunctions.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.Also nogales site opened capa to perform an investigation.Rationale: 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.

Event Description

It was reported that the connecta plus3 7 cm white blend experienced leakage during use.

• Brand Name: CONNECTA PLUS3 7 CM WHITE BLEND
• 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: 8372085
• MDR Text Key: 137516964
• Report Number: 9610847-2019-00186
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Reporter Country Code: EN
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 394945
• Device Lot Number: SEE H.10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/06/2019
• Was Device Evaluated by Manufacturer?: No
• 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