MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD CONNECTA¿ WHT 360DEG TB 25CM; STOPCOCK

Catalog Number 394926

Device Problem Leak/Splash (1354)

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

Event Date 11/05/2019

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 tube disconnects from the valve during injection with a bd connecta¿ wht 360deg tb 25cm.This occurred on 4 separate occasions during use, however, the date/time and or patient information is unknown.The following information was provided by the initial reporter, translated from (b)(6) to english: the tube disconnects from the valve during injection.

Event Description

It was reported that the tube disconnects from the valve during injection with a bd connecta¿ wht 360deg tb 25cm.This occurred on 4 separate occasions during use, however, the date/time and or patient information is unknown.The following information was provided by the initial reporter, translated from french to english: the tube disconnects from the valve during injection.

Manufacturer Narrative

H.6 investigation summary: a device history record review was completed by our quality engineer team for provided lot number 9066783.The review did not reveal any detected abnormalities during the production process that could have contributed to this defect and all quality tests were found to be within specification.As a sample was unavailable for return, a thorough sample investigation could not be completed.Based on the investigation results, an exact cause for this incident could not be identified.There are quality controls currently in place to detect this type of defect during the production process.The incident description states that the tube disconnects from the valve during the injection; it is important to note that the connecta products are not for use with pressure.Further action has not been determined necessary at this time.Our quality team will continue to monitor the manufacturing process for this defect and other emerging trends.

• Brand Name: BD CONNECTA¿ WHT 360DEG TB 25CM
• 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: 9361480
• MDR Text Key: 191729768
• Report Number: 9610847-2019-00694
• 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: 01/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 02/28/2022
• Device Catalogue Number: 394926
• Device Lot Number: 9066783
• Date Manufacturer Received: 11/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other