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

Catalog Number 394945

Device Problem Fluid/Blood Leak (1250)

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

Event Date 12/10/2018

Event Type  malfunction  

Manufacturer Narrative

Multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 8226712, medical device expiration date: 2021-07-31, device manufacture date: 2018-09-24.Medical device lot #: 8180507, medical device expiration date: 2021-05-31, device manufacture date: 2018-08-30.(b)(6).A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that bd connecta¿ stopcock injection valve leaks.No serious injury or medical intervention was reported.

Manufacturer Narrative

Investigation summary: a device history review was conducted for lot numbers 8226712 and 8180507.Our records show that this is the only instance of this issue occurring in either connect a batch.According to the sampling plan applied for product performance, each lot was accepted and released without defects being noted during the final assembly or visual inspections.Additionally, our engineers were able to duplicate this event through the leakage testing of the submitted device.A subsequent review of our manufacturing line determined that the most likely root cause for this event is an abnormality in the equipment responsible for tubing assembly.To prevent a reoccurrence of this event we have retrained our personnel and optimized our manufacturing process to monitor this issue more thoroughly.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 bd connecta¿ stopcock injection valve leaks.No serious injury or medical intervention was reported.

• 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: 8196756
• MDR Text Key: 131590031
• Report Number: 9610847-2018-00460
• 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: 02/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2018
• 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
• Date Manufacturer Received: 12/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other