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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; STOPCOCK
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BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. CONNECTA Q-SYTE WHT; STOPCOCK Back to Search Results
Catalog Number 394501
Device Problem Leak/Splash (1354)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/22/2020
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.(b)(4).
 
Event Description
It was reported that the cap separated from the connecta q-syte wht stopcock.The following information was provided by the initial reporter, translated from (b)(4) to english: "the customer reported that the lock ring of stopcock had been separated.".
 
Manufacturer Narrative
H6: investigation summary: a device history record review was completed for provided lot number 9336383.The review did not reveal any detected abnormalities during the production process that could have contributed to this defect and all quality tests were found to be within specification.To aid in the investigation of this issue, a picture sample was evaluated by our quality engineer team.Through examination of the picture bd was not able to confirm that the reported failure was related to a bd process.The automated manufacturing process has the ability to identify the presence of a missing or detached component before proceeding to the next operational step and no issues were identified during the production process.If this defect was noticed prior to use of the product, it is important to keep the product within the packaging to assist in the identification of the possible root causes related to the manufacturing process alone.H3 other text : see h10.
 
Event Description
It was reported that the cap separated from the connecta q-syte wht stopcock.The following information was provided by the initial reporter, translated from japanese to english: "the customer reported that the lock ring of stopcock had been separated.".
 
Manufacturer Narrative
H.6.Investigation: a device history record review was completed for provided lot number 9336383.The review did not reveal any detected abnormalities during the production process that could have contributed to this defect and all quality tests were found to be within specification.To aid in the investigation of this issue, both a picture and the affected sample were returned for evaluation by our quality engineer team.The sample was visually inspected and the luer lock component was observed separated from the housing.The luer lock component was inserted into the housing to perform a functionality test, which identifies the torque between the two pieces and detects the connection between them.All of the results from this test were approved.The automated manufacturing process has the ability to identify the presence of a missing or detached component before proceeding to the next operational step; however, no issues were identified during the production of lot 9336383.The possibility of a variation in the dimensions of the raw materials used which would allow for easy separation, has been ruled out as the functional test proved the components met specifications and had the correct dimensions.Another possible cause for this incident could be misuse.If an excessive connection force is used when handling the product, the components may become detached.If this defect was noticed prior to use of the product, it is important to keep the product within the packaging to assist in the identification of the possible root causes related to the manufacturing process alone.H3 other text : see h.10.
 
Event Description
It was reported that the cap separated from the connecta q-syte wht stopcock.The following information was provided by the initial reporter, translated from japanese to english: "the customer reported that the lock ring of stopcock had been separated.".
 
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Brand Name
CONNECTA Q-SYTE WHT
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 Key11181288
MDR Text Key227755225
Report Number9610847-2021-00017
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,Followup
Report Date 05/11/2021
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 Expiration Date11/30/2022
Device Catalogue Number394501
Device Lot Number9336383
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/28/2020
Initial Date Manufacturer Received 12/22/2020
Initial Date FDA Received01/15/2021
Supplement Dates Manufacturer Received04/13/2021
05/11/2021
Supplement Dates FDA Received04/19/2021
05/25/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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