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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 10CM WHITE; STOPCOCK
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BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. CONNECTA PLUS3 10CM WHITE; STOPCOCK Back to Search Results
Catalog Number 394995
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Patient Involvement (2645)
Event Date 10/12/2020
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 10cm white had foreign matter.The following information was provided by the initial reporter: sealed packaging contained spots of black debris.Sealed packaging of 3 way tap with extension noted to contain multiple small spots of black debris.Customer checked the other products on the box but did not find any others that were affected.
 
Event Description
It was reported that connecta plus3 10cm white had foreign matter.The following information was provided by the initial reporter: sealed packaging contained spots of black debris.Sealed packaging of 3 way tap with extension noted to contain multiple small spots of black debris.Customer checked the other products on the box but did not find any others that were affected.
 
Manufacturer Narrative
H.6.Investigation: a device history record review was performed for provided lot number 8184760 and the review did not reveal any detected quality issues during the production process that could have contributed to this reported incident.To aid in the investigation of this issue, the sample was returned for evaluation by our quality engineer team.Through examination, black spots were detected on the product packaging.It has been determined that the black spots resulted from the machinery used within the manufacturing process.H3 other text : see h.10.
 
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Brand Name
CONNECTA PLUS3 10CM 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 Key10795206
MDR Text Key219378939
Report Number9610847-2020-00343
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 11/24/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/05/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date06/30/2021
Device Catalogue Number394995
Device Lot Number8184760
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/19/2020
Date Manufacturer Received11/24/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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