MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. CONNECTA Q-SYTE WHT; STOP COCK

Catalog Number 394501

Device Problems Device Damaged Prior to Use (2284); Detachment of Device or Device Component (2907)

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

Event Date 01/18/2019

Event Type  malfunction  

Manufacturer Narrative

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 a connecta q-syte wht had a detached lock-ring when the package was opened.

Event Description

It was reported that a connecta q-syte wht had a detached lock-ring when the package was opened.

Manufacturer Narrative

H.6.Investigation summary: a device history review was conducted for lot number 8121553.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.Additionally the sample submitted by your facility was reviewed, our quality engineers were able to identify silicon residue on port a, indicating that the root cause excess application of silicon to the device.Bd was able to duplicate or confirm the customer¿s indicated failure mode.Customer reported detached lock ring issues; sample have been functional tested and visual inspected showing problems (disconnection and silicone presence); after sample evaluation by the engineering team, the potential causes for luer lock detachment is a wrong assembly or the silicon presence on port a; unfortunately, the package was opened and sample handled prior investigation to discard one of the two potential failure modes.Reviewing maintenance records for equipment under investigation, nothing extraordinary was reported and no repairs performed during lot production on stations 03 and 06.Quality records (internal rejects) have been consulted for tracking and trending purposes and no issues like this are detected.Issue previously reported in customer complaints but only 3 times confirmed for connecta product family, however, only two customer complaints were confirmed with a probable root cause of silicone presence (during 2013-2018).The complaint rate remains historically low levels as observed on records which means pretty low occurrence.Process fmea rm5895 and eurap2053001 were reviewed and there are proper controls in place to detect product malfunctions.Based on investigation results to date, root cause is associated to station 03 and station 06.

• Brand Name: CONNECTA Q-SYTE WHT
• Type of Device: STOP COCK
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales
• MDR Report Key: 8351876
• MDR Text Key: 136856618
• Report Number: 9610847-2019-00175
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00382903945016
• UDI-Public: 382903945016
• 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: 03/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2019
• 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: 394501
• Device Lot Number: 8121553
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2019
• Date Manufacturer Received: 01/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other