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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. CONNECTA Q-SYTE WHT
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BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. CONNECTA Q-SYTE WHT Back to Search Results
Catalog Number 394501
Device Problem Leak/Splash (1354)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/05/2019
Event Type  malfunction  
Manufacturer Narrative
Device expiration date: unknown.Device manufacture date: unknown.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 blood leakage occurred during use with a connecta q-syte wht.The following information was provided by the initial reporter, "blood leaked from between the white part and the clear part when pumping from the side tube of the stop cock.The issue occurs every time when using it not only this time, in this lot.Customer strongly requested to improve the quality otherwise they may change to 3rd party product.".
 
Manufacturer Narrative
H.6.Investigation: as neither a sample nor a lot number was available for this incident, our quality team was unable to complete a sample evaluation or review the production history for this product.There are current quality controls in place to detect this type of product malfunction during the production process.Based on the limited investigation results, a cause for the reported incident could not be determined.Dhr could not be performed due to unknown lot#.
 
Event Description
It was reported that blood leakage occurred during use with a connecta q-syte wht.The following information was provided by the initial reporter.Blood leaked from between the white part and the clear part when pumping from the side tube of the stop cock.The issue occurs every time when using it not only this time, in this lot.Customer strongly requested to improve the quality otherwise they may change to 3rd party product.
 
Event Description
It was reported that blood leakage occurred during use with a connecta q-syte wht.The following information was provided by the initial reporter, "blood leaked from between the white part and the clear part when pumping from the side tube of the stop cock.The issue occurs every time when using it not only this time, in this lot.Customer strongly requested to improve the quality otherwise they may change to 3rd party product.".
 
Manufacturer Narrative
H.6.Investigation: a device history record review was performed for both of the potential provided lot numbers; 9059723 & 9093766.The review did not reveal any detected quality issues during the production process that could have contributed to the reported incident.All quality tests, including quality leakage tests, completed during the production process were within the acceptance criteria.As neither a picture sample nor a physical sample was available for return, our quality team was unable to complete a thorough sample investigation.There are current quality controls in place to detect this type of product malfunction during the production process.Based on the limited investigation results, a cause for the reported incident could not be determined.H3 other text : see h.10.
 
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Brand Name
CONNECTA Q-SYTE WHT
Type of Device
CONNECTA
Manufacturer (Section D)
BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
periferico luis donaldo
colosio no. 579
nogales
MX 
MDR Report Key9522114
MDR Text Key192062280
Report Number9610847-2019-00770
Device Sequence Number1
Product Code FMG
Combination Product (y/n)N
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Type of Report Initial,Followup,Followup
Report Date 02/12/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/26/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number394501
Device Lot NumberUNKNOWN
Date Manufacturer Received12/05/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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