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

Catalog Number 394600

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems High Blood Pressure/ Hypertension (1908); Extubate (2402); Low Oxygen Saturation (2477)

Event Date 01/15/2019

Event Type  malfunction  

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 the bd connecta¿ stopcock leaked during use, causing the patient to "wake up with hypertension, desaturation, extubation risk and hemodynamic alteration".However, there was no medical intervention reported.This event was reported to have occurred twice, but the specific patient data and/or date/time is unknown.

Event Description

It was reported that the bd connecta¿ stopcock leaked during use, causing the patient to "wake up with hypertension, desaturation, extubation risk and hemodynamic alteration".However, there was no medical intervention reported.This event was reported to have occurred twice, but the specific patient data and/or date/time is unknown.

Manufacturer Narrative

H.6.Investigation: in response to the event reported by your facility a device history review was conducted for lot number 8256665.Our records show that this is the only instance of leakage occurring 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 the sample submitted by your facility was subjected to leakage testing and found to be operating within product specifications, exhibiting no signs of leakage or other non-conformances.Unfortunately without the ability to duplicate or observe the reported failure mode, the root cause for this complaint could not be determined at the conclusion of our review.Bd was not able to duplicate or confirm the customer¿s indicated failure mode.

• 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: 8351430
• MDR Text Key: 136581963
• Report Number: 9610847-2019-00174
• 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,health professional,o
• Type of Report: Initial,Followup
• Report Date: 03/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 08/31/2021
• Device Catalogue Number: 394600
• Device Lot Number: 8256665
• Date Manufacturer Received: 02/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 18 YR