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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 PLUS3 WHITE; STOPCOCK
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BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. CONNECTA PLUS3 WHITE; STOPCOCK Back to Search Results
Catalog Number 394600
Device Problem Complete Blockage (1094)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/10/2020
Event Type  malfunction  
Manufacturer Narrative
Investigation summary: a device history record review was completed by our quality engineer team for provided lot number 9154903.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.As a sample was unavailable for return, a thorough sample investigation could not be completed.Based on the investigation results, an exact cause for this incident could not be identified.There are quality controls currently in place to detect this type of defect during the production process.Further action has not been determined necessary at this time.Our quality team will continue to monitor the manufacturing process for this defect and other emerging trends.Investigation conclusion: bd was not able to duplicate or confirm the customer¿s indicated failure mode.It is recommended send the sample involved to perform a better investigation.Quality records have been consulted for tracking and trending purposes and no issues like this are detected which means pretty low occurrence.Process (b)(4) and process (b)(4) were reviewed and there are proper controls in place to detect product malfunctions.We will keep monitoring the manufacturing process and in case any emerging trend is detected, further actions will be taken if necessary.Root cause description: based on investigation results to date, root cause for manufacturing process cannot be determined.Rationale: no ¿ based on an evaluation of severity and frequency it was determined that no corrective action is required at this time also the root cause was not identified, therefore, corrective and preventive actions were not implemented.
 
Event Description
It was reported that the connecta plus3 white experienced flow issues during use.The following information was provided by the initial reporter: unable to start infusion.Connecta connected to extension line to a syringe within a syringe pump and when pump infusion commenced, the infusion would not run and it was found that the product was the cause.
 
Manufacturer Narrative
H.6.Investigation summary: a device history record review was completed by our quality engineer team for provided lot number 9154903.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 further investigate this issue, one physical sample was returned for evaluation by our quality engineer team.The sample was functionally tested and no signs of leakage were observed.The sample was then visually inspected, but no possible signs of occlusion or damage were detected.The reported incident could not be duplicated within the manufacturing facility.Based on the investigation results, a manufacturing related cause could not be determined for this incident.Our quality team will continue to monitor the production process for signs of potential defects and other emerging trends.
 
Event Description
It was reported that the connecta plus3 white experienced flow issues during use.The following information was provided by the initial reporter: unable to start infusion.Connecta connected to extension line to a syringe within a syringe pump and when pump infusion commenced, the infusion would not run and it was found that the product was the cause.
 
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Brand Name
CONNECTA PLUS3 WHITE
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 Key9773677
MDR Text Key205004878
Report Number9610847-2020-00064
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
Report Date 03/27/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/02/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date05/31/2022
Device Catalogue Number394600
Device Lot Number9154903
Date Manufacturer Received02/11/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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