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

Catalog Number 395246

Device Problem Complete Blockage (1094)

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.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It has been reported that one stpck q-syte red 360deg w/o nut cap ns has been found experiencing flow issues during use.The following has been provided by the initial reporter: when priming with heparin and saline, hcp complained the main port part wasn't locked.(it didn't flow).

Manufacturer Narrative

Investigation summary: a device history review was conducted for lot number 8213745.Our records show that this is the only instance of this issue occurring in this production batch.According to the sampling plan applied for product performance, this lot was accepted and released without defects being noted during the final assembly or visual inspections.The returned device was subjected to occlusion testing and found to be free of any observable or testable obstruction.Based on our testing results, the root cause for this complaint could not be determined at the conclusion of our review.

Event Description

It has been reported that one stpck q-syte red 360deg w/o nut cap ns has been found experiencing flow issues during use.The following has been provided by the initial reporter: when priming with heparin and saline, hcp complained the main port part wasn't locked.(it didn't flow).

• Brand Name: STPCK Q-SYTE RED 360DEG W/O NUT CAP NS
• 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: 9152094
• MDR Text Key: 191040349
• Report Number: 9610847-2019-00599
• 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

• Date FDA Received: 10/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 395246
• Device Lot Number: 8213745
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2019
• Date Manufacturer Received: 09/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other