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

Catalog Number 394602

Device Problem Leak/Splash (1354)

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

Event Date 04/04/2019

Event Type  malfunction  

Manufacturer Narrative

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.

Event Description

It was reported that leakage occurred during use with a bd connecta¿ stopcock.The following information was provided by the initial reporter, translated from (b)(6) to english: rupture at transparent interface, causing liquid leakage.

Event Description

It was reported that leakage occurred during use with a bd connecta¿ stopcock.The following information was provided by the initial reporter, translated from chinese to english: rupture at transparent interface, causing liquid leakage.

Manufacturer Narrative

H.6.Investigation: a device history record review was completed for the provided lot number.The review did not reveal any detected abnormalities during the production process that could have contributed to this incident.As a sample was unavailable for this incident, a thorough sample investigation could not be completed by our quality team.Based on the investigation results, a cause for the reported incident could not be determined.Quality records were reviewed for tracking and trending purposes and it has been determined that this issue was an isolated occurrence.

• 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 ; MX
• MDR Report Key: 9496361
• MDR Text Key: 192060381
• Report Number: 9610847-2019-00754
• 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: 01/17/2020

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 Expiration Date: 04/30/2021
• Device Catalogue Number: 394602
• Device Lot Number: 8121537
• Initial Date Manufacturer Received: 12/04/2019
• Initial Date FDA Received: 12/19/2019
• Supplement Dates Manufacturer Received: 12/04/2019
• Supplement Dates FDA Received: 01/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other