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

Catalog Number 394501

Device Problem Leak/Splash (1354)

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

Event Date 11/26/2019

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 detached ring occurred during use with a connecta q-syte wht.The following information was provided by the initial reporter, "the lock ring was detached.".

Event Description

It was reported that a detached ring occurred during use with a connecta q-syte wht.The following information was provided by the initial reporter, "the lock ring was detached.".

Manufacturer Narrative

H.6.Investigation: three physical samples were provided for evaluation by our quality engineer team.Through examination of the returned samples, damage was observed at the luer connection location.The samples were functionally tested and the samples were found to disconnect.The potential causes for luer-lok disconnection are incorrect assembly or excessive silicone presence.Excessive silicone was not observed on the returned samples.As the returned samples were used and had slight damage to the luer connection location, our quality team was unable to determine whether this incident was a result of an error in assembly of the product or incorrect usage.If the damage to the luer connection occurred within the manufacturing environment, it is possible that it occurred within station 3 of the assembly line.This station is where the luer-lok component is assembled to the housing.If a misalignment was present in the assembly equipment, it could result in the observed damage.A quality alert has been issued within the manufacturing facility for this incident.

• Brand Name: CONNECTA Q-SYTE WHT
• Type of Device: CONNECTOR
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• MDR Report Key: 9467560
• MDR Text Key: 192057767
• Report Number: 9610847-2019-00741
• 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: 01/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 394501
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2019
• Date Manufacturer Received: 11/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other