MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD CONNECTA¿ STOPCOCK WITH VALVE AND EXTENSION TUBING

Catalog Number 394971

Device Problem Leak/Splash (1354)

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

Event Date 10/17/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.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 the bd connecta¿ stopcock with valve and extension tubing leaked from the administration port during use and onto the patient's pillow.The following information was provided by the initial reporter: "they stated iv fluids were leaking from the administration port next to the 3 way tap.Fluid leaked out and patients pillow was wet.".

Manufacturer Narrative

Investigation summary: a device history review was conducted for lot number 8215502.Our records show a trend for this issue has been detected in this batch of bd connecta.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.Additionally, although our engineers were unable to obtain a device for test, previous investigations and 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 re-occurrence of this event we have retrained our personnel and optimized our manufacturing process to monitor this issue more thoroughly.Bd was not able to duplicate or confirm the failure mode because samples or pictures were not provided, however, since this batch have 12 complaints related to leakage this failure mode could be produced due 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.Conclusion: 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.

Event Description

It was reported that the bd connecta¿ stopcock with valve and extension tubing leaked from the administration port during use and onto the patient's pillow.The following information was provided by the initial reporter: "they stated iv fluids were leaking from the administration port next to the 3 way tap.Fluid leaked out and patients pillow was wet.".

• Brand Name: BD CONNECTA¿ STOPCOCK WITH VALVE AND EXTENSION TUBING
• Type of Device: STOPCOCK
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• MDR Report Key: 9262332
• MDR Text Key: 194704530
• Report Number: 9610847-2019-00658
• 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: 11/20/2019

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: Other
• Device Expiration Date: 07/31/2021
• Device Catalogue Number: 394971
• Device Lot Number: 8215502
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/17/2019
• Initial Date FDA Received: 10/31/2019
• Supplement Dates Manufacturer Received: 10/17/2019
• Supplement Dates FDA Received: 11/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other