MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD STOPCOCK Q-SYTE¿ 360DEG W/O NUT CAP

Catalog Number 395242

Device Problem Leak/Splash (1354)

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

Event Date 08/03/2018

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.Initial reporter facility name: (b)(6) hospital.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 leakage occurred from the adhesion part between the tube under the filter and the tube of the bd stopcock q-syte¿ 360deg w/o nut cap.There was no report of exposure, injury or medical intervention.

Manufacturer Narrative

Unfortunately a lot number could not was not submitted for this complaint, and could not be determined from the photographs provided.Preventing our investigation team from conducting a device history review.A photograph was provided for the purpose of aiding our quality engineer's investigation, unfortunately a sample could not be obtained for leakage testing.Without the ability to test the affected unit for this event our quality engineers were unable to determine the root cause for this complaint.However, bd will continue to monitor this issue and encourages you to submit your sample for review.Based on investigation results to date, root cause for manufacturing process cannot be determined.

Event Description

It was reported that leakage occurred from the adhesion part between the tube under the filter and the tube of the bd stopcock q-syte 360deg w/o nut cap.There was no report of exposure, injury or medical intervention.

• Brand Name: BD STOPCOCK Q-SYTE¿ 360DEG W/O NUT CAP
• 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: 7818603
• MDR Text Key: 118408640
• Report Number: 9610847-2018-00271
• 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: 09/25/2018

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: 395242
• Device Lot Number: UNKNOWN
• Initial Date Manufacturer Received: 08/07/2018
• Initial Date FDA Received: 08/27/2018
• Supplement Dates Manufacturer Received: 08/07/2018
• Supplement Dates FDA Received: 09/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other