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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE; INTRAVASCULAR CATHETER
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BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE; INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 385100
Device Problems Crack (1135); Difficult to Remove (1528)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/26/2019
Event Type  malfunction  
Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation and/or device history review, a supplemental report will be filed.
 
Event Description
It was reported that during use of the bd q-syte¿ luer access split-septum stand-alone device the connector was placed about 5 days, the q-syte connector was quite difficult to be removed in preparation of injection.The connector was cracked after removed by force.The injected medicine were liver serax and eddie.Foreign complaint the following information was provided by the initial reporter, translated from chinese to english: the connector was placed about 5 days, the q-syte connector was quite difficult to be removed in preparation of injection.The connector was cracked after removed by force.The injected medicine were liver serax and eddie.
 
Event Description
It was reported that during use of the bd q-syte¿ luer access split-septum stand-alone device the connector was placed about 5 days, the q-syte connector was quite difficult to be removed in preparation of injection.The connector was cracked after removed by force.The injected medicine were liver serax and eddie.Foreign complaint the following information was provided by the initial reporter, translated from chinese to english: the connector was placed about 5 days, the q-syte connector was quite difficult to be removed in preparation of injection.The connector was cracked after removed by force.The injected medicine were liver serax and eddie.
 
Manufacturer Narrative
H.6.Investigation: bd received a q-syte unit from lot 8115557 for evaluation.A review of the device history record was performed for the reported lot and no quality issues were found during production.Our quality engineer visually inspected the returned unit and observed that the top and bottom bodies were separated at the weld joint location.The septum and neck of the top body was separated from the rest of the body.However, there was adequate traces of a weld line on the rims of the top and bottom bodies to show that a weld was made during production.Also, the bottom half of the top body was cracked.The engineer was unable to verify the reported issue of the q-syte being difficult to remove however, the engineer was able to verify that the unit was damaged and in three separate pieces.There was no physical or mechanical evidence to confirm or support the manufacturing process as the cause of this issue.
 
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Brand Name
BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE
Type of Device
INTRAVASCULAR CATHETER
Manufacturer (Section D)
BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
periferico luis donaldo
colosio no. 579
nogales
MDR Report Key8551078
MDR Text Key145653921
Report Number9610847-2019-00329
Device Sequence Number1
Product Code FPA
UDI-Device Identifier30382903851004
UDI-Public30382903851004
Combination Product (y/n)N
PMA/PMN Number
K013621
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Type of Report Initial,Followup
Report Date 06/12/2019
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 Health Professional
Device Expiration Date04/30/2023
Device Catalogue Number385100
Device Lot Number8115557
Initial Date Manufacturer Received 04/03/2019
Initial Date FDA Received04/25/2019
Supplement Dates Manufacturer Received04/03/2019
Supplement Dates FDA Received06/13/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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