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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 RED; STOPCOCK
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BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. CONNECTA PLUS3 RED; STOPCOCK Back to Search Results
Catalog Number 394605
Device Problems Break (1069); Leak/Splash (1354)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/28/2020
Event Type  malfunction  
Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).
 
Event Description
It was reported that connecta plus3 red was damaged.The following information was provided by the initial reporter: the patient was admitted to the hospital on (b)(6) 2020 due to being unconscious by his family found for 40 minutes.Continuous blood purification was performed during hospitalization, and the connecta was broken during the treatment.
 
Event Description
It was reported that connecta plus3 red was damaged.The following information was provided by the initial reporter: the patient was admitted to the hospital on (b)(6) 2020 due to being unconscious by his family found for 40 minutes.Continuous blood purification was performed during hospitalization, and the connecta was broken during the treatment.
 
Manufacturer Narrative
H6: investigation summary a device history record review was completed by our quality engineer team for provided lot number 0006969.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.Per the provided feedback of ¿connecta was broken during treatment,¿ the device can be broken due to incorrect use or incorrect connection.It is important to closely follow the instructions for use when handling the connecta product.See h.10.
 
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Brand Name
CONNECTA PLUS3 RED
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 Key11091618
MDR Text Key227033592
Report Number9610847-2020-00435
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 02/04/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/29/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date12/31/2022
Device Catalogue Number394605
Device Lot Number0006969
Was Device Available for Evaluation? No
Date Manufacturer Received02/04/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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