MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD CONNECTA¿ PLUS STOPCOCK WITH EXTENSION LINE; STOP COCK

Catalog Number 394995

Device Problem Leak/Splash (1354)

Patient Problems Hemorrhage/Bleeding (1888); Hypovolemia (2243)

Event Date 02/05/2018

Event Type  Injury  

Manufacturer Narrative

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 during use, a bd connecta¿ stopcock was found leaking as ¿the cap of the three way stop cock's secondary line was disconnected.¿ due to this malfunction the ¿patient suffered bleeding/ hypovolemia.¿ no further information requiring medical intervention was reported.

Manufacturer Narrative

Investigation summary: bd was not able to duplicate or confirm the customer¿s indicated failure mode.Customer reported cap detachment and blood excess/splash/spill/exposure issues; however, we were not able to reproduce the reported failure modes with samples provided.Quality records have been consulted for tracking and trending purposes and no issues like these are detected which means pretty low occurrence.Product is functional tested and no incidents with plug removals and leakages have been reported.Process fmea rm5943 was reviewed and there are proper controls in place to detect product malfunctions.Always refer to ifu for product usage recommendations.We will keep monitoring the manufacturing process and in case any emerging trend is detected, further actions will be taken if necessary.Material 394995 with lot numbers 7275924 and 7247624 were manufactured on oct-08-2017 and sep-19-18 respectively by equipment ka56.No qn's or other extraordinary events have been related to the complaint.Investigation conclusion: based on investigation results to date, root cause for manufacturing process cannot be determined.

• Brand Name: BD CONNECTA¿ PLUS STOPCOCK WITH EXTENSION LINE
• Type of Device: STOP COCK
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales
• MDR Report Key: 7309363
• MDR Text Key: 101370033
• Report Number: 9610847-2018-00055
• 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: 03/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 09/30/2020
• Device Catalogue Number: 394995
• Device Lot Number: 7275924
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2018
• Date Manufacturer Received: 02/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other