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

Catalog Number 394945

Device Problem Fluid/Blood Leak (1250)

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

Event Date 10/24/2018

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.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 leaked.No serious injury or medical intervention was reported.

Manufacturer Narrative

H.6.Investigation summary: a device history review was conducted for lot number 634962.A review of our records determined that this is the third instance of leakage 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 of packaged goods.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.Specifically for this record photos or samples were not received, which is necessary to perform a better investigation, therefore, bd nogales can¿t conclude the failure reported by the customer.However, for leakage issue in leakage/air in injection valve that have been detected in others customer complaints, the team previously confirmed issues with this product lot 8037509 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 (b)(4) and process eura (b)(4) were reviewed and there are proper controls in place to detect product malfunctions.For leakage issue (in injection valve, batch 8037509) based on investigation results to date, root cause was associated to a bad tubing assembly by station 5 of equipment vh59.Nogales will open a capa (#629955) not because of the cid as it is ¿no capa required¿ as per (b)(4) based on the severity and occurrence calculation, the reason to open the capa is to better support the exposure to external stakeholders, the focus of the capa will be batch 8037509 and sub-assembly lots related to that batch.

Event Description

It was reported that bd connecta¿ stopcock leaked.No serious injury or medical intervention was reported.

• Brand Name: BD CONNECTA¿ STOPCOCK LEAKED
• 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: 8019170
• MDR Text Key: 125647304
• Report Number: 9610847-2018-00376
• 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: 11/27/2018

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: Other
• Device Expiration Date: 04/30/2021
• Device Catalogue Number: 394945
• Device Lot Number: 8149878
• Initial Date Manufacturer Received: 10/24/2018
• Initial Date FDA Received: 10/30/2018
• Supplement Dates Manufacturer Received: 10/24/2018
• Supplement Dates FDA Received: 11/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other