MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD CONNECTA Q-SYTE; STOPCOCK

Catalog Number 394501

Device Problem Leak/Splash (1354)

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

Event Date 03/01/2020

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.Initial reporter phone #: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that stopcock detached during use with a bd connecta q-syte¿.The following information was provided by the initial reporter, translated from (b)(6) to english: luer lock ring was detached.

Manufacturer Narrative

H.6.Investigation: to aid in the investigation of this incident, a sample was originally sent to our bd japan facility.The sample is not available for further evaluation at our mexico based manufacturing facility due to covid-19 concerns.Pictures provided by bd japan were used for the investigation.A thorough investigation utilizing other methodologies and available information was completed to the best of our ability.Through examination of the pictures, luer-lok collar breakage was observed.It is possible that this damage resulted from incorrect assembly within the manufacturing facility or excessive silicone presence.A quality alert has been issued to the applicable manufacturing personnel to raise awareness for this potential defect.As a lot number was unavailable for this product, a review of the production history could not be performed.Based on investigation results to date, probable root causes can be associated to station 03 (wrong assembly of luer) or incorrect customer use.

Event Description

It was reported that stopcock detached during use with a bd connecta q-syte¿.The following information was provided by the initial reporter, translated from japanese to english: luer lock ring was detached.

• Brand Name: BD CONNECTA Q-SYTE
• 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: 9868316
• MDR Text Key: 195312131
• Report Number: 9610847-2020-00104
• 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: 04/03/2020

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 Catalogue Number: 394501
• Device Lot Number: UNKNOWN
• Initial Date Manufacturer Received: 03/02/2020
• Initial Date FDA Received: 03/23/2020
• Supplement Dates Manufacturer Received: 03/02/2020
• Supplement Dates FDA Received: 04/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other