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

Catalog Number 394997

Device Problem Burst Container or Vessel (1074)

Patient Problems Chemical Exposure (2570); No Known Impact Or Consequence To Patient (2692)

Event Date 12/07/2018

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 with the use of the bd connecta¿ stopcock there were 2 occurences with one of the extensions bursting mixing contrast agent with blood spreading through device and on patient.

Event Description

It was reported with the use of the bd connecta¿ stopcock there were 2 occurences with one of the extensions bursting mixing contrast agent with blood spreading through device and on patient.

Manufacturer Narrative

H.6.Investigation: a device history review was conducted for lot number 606706.Our records show that this is the only instance of this issue 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.Additionally our quality engineer reviewed the devices submitted by your facility.Of the 44 samples returned two failed leakage testing , further inspection of these devices identified damaged tubing, the remaining samples performed as expected in accordance with product specifications.The damage observed in the tubing and your description of events indicate that the device was used under pressurized conditions.It is the use of pressure during the use of this device that most likely lead to the damage observed.Please note that the mdr connecta is intended for infusion only and is not rated for use under pressure.

• 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: 8241727
• MDR Text Key: 132931858
• Report Number: 9610847-2018-00469
• 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: 03/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 03/01/2019
• Device Catalogue Number: 394997
• Device Lot Number: 6068706
• Date Manufacturer Received: 12/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other