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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. STOPCOCK Q-SYTE WHT 360DEG NONSTERILE
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BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. STOPCOCK Q-SYTE WHT 360DEG NONSTERILE Back to Search Results
Catalog Number 395240
Device Problem Leak/Splash (1354)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/21/2020
Event Type  malfunction  
Manufacturer Narrative
Device expiration date: unknown a device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.(b)(4).
 
Event Description
It was reported that the stopcock q-syte wht 360deg nonsterile experienced leakage.The following information was provided by the initial reporter: during infusion of kcl using infusion set connected to q-syte of 385408-zat, the fluid leaked from the connection due to a defective connector.
 
Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 2021-02-17 h6: investigation summary to aid in the investigation of this issue, the affected sample was returned to bd for evaluation by our quality engineer team.Through examination of the sample, the septum top disk component was observed separated from the top body of the q-syte component.The column of the septum is torn away.There is a visibly large tear at the septum column wall, which is indicative of leakage.During the manufacturing process when the septum slit is created, tears to the column wall may occur when the probe enters the slit due to a misalignment.Checks for alignment are performed during the preventive maintenance process.As a lot number was unknown for this incident, a review of the production history records could not be completed.Regular inspections are performed to test for septum leakage and damage, however, the observed degree of damage to the septum column is not normally seen during the manufacturing process.During the manufacturing process, septum misorientation or uneven deposition of adhesive may result in damage to the q-syte or septum detachment.Visual observations reveal residual adhesive deposits on the rim of the top body component, indicating that that a uniform bond was made at the time of manufacture.Damage was not observed to the top body nor were there signs of septum misorientation.It is possible that the observed damaged resulted from excessive actuations or extraneous force.The separation of the top disk can also result from extraneous force.It is possible that the septum column tear existed as a manufacturing defect and then was exacerbated through use, however, this cannot be confirmed.See h10.
 
Event Description
It was reported that the stopcock q-syte wht 360deg nonsterile experienced leakage.The following information was provided by the initial reporter: during infusion of kcl using infusion set connected to q-syte of 385408-zat, the fluid leaked from the connection due to a defective connector.
 
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Brand Name
STOPCOCK Q-SYTE WHT 360DEG NONSTERILE
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 Key11182493
MDR Text Key228226644
Report Number9610847-2021-00024
Device Sequence Number1
Product Code FMG
Combination Product (y/n)N
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Type of Report Initial,Followup
Report Date 03/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number395240
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/17/2021
Initial Date Manufacturer Received 12/24/2020
Initial Date FDA Received01/15/2021
Supplement Dates Manufacturer Received03/12/2021
Supplement Dates FDA Received03/18/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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