MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD STOPCOCK Q-SYTE RED 360DEG NONSTERILE

Catalog Number 395245

Device Problem Leak/Splash (1354)

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

Event Date 09/17/2019

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 during use drug leaked from unspecified location with a bd stopcock q-syte red 360deg nonsterile.The following information was provided by the initial reporter, translated from japanese to english: drug leaked from the route.

Manufacturer Narrative

Investigation: unfortunately a lot number could not be submitted for this complaint, and could not be determined from the photographs provided.Preventing our investigation team from conducting a device history review.Although photos were submitted for evaluation, they did not display the failure mode clearly enough to identify the root cause.Unfortunately a sample could not be obtained for evaluation and testing.Without the ability to investigate the affected unit our quality engineers were unable to determine the root cause for this complaint.

Event Description

It was reported that during use drug leaked from unspecified location with a bd stopcock q-syte red 360deg nonsterile.The following information was provided by the initial reporter, translated from japanese to english: drug leaked from the route.

• Brand Name: BD STOPCOCK Q-SYTE RED 360DEG NONSTERILE
• 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: 9152318
• MDR Text Key: 169081302
• Report Number: 9610847-2019-00600
• 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: 11/19/2019

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: 395245
• Device Lot Number: UNKNOWN
• Initial Date Manufacturer Received: 09/17/2019
• Initial Date FDA Received: 10/03/2019
• Supplement Dates Manufacturer Received: 09/17/2019
• Supplement Dates FDA Received: 11/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other