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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 BLEND; STOPCOCK
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BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. CONNECTA PLUS3 WHITE BLEND; STOPCOCK Back to Search Results
Catalog Number 394900
Device Problem Leak/Splash (1354)
Patient Problem No Patient Involvement (2645)
Event Date 10/28/2020
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 connecta plus3 white blend experienced luer lok collar breakage.The following information was provided by the initial reporter: before use, the hcp found separation of the luer lock ring.
 
Event Description
It was reported that the connecta plus3 white blend experienced luer lok collar breakage.The following information was provided by the initial reporter: before use, the hcp found separation of the luer lock ring.
 
Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval? yes.D10: returned to manufacturer on: 2020-12-14.H6: investigation summary: a device history record review was performed for provided lot number 9305663 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, pictures and the physical sample were returned for evaluation by our quality engineer team.Through examination of the sample, the luer-lock ring was observed detached.This type of defect may result from excessive silicone; however, the production records did not reveal any detection of this potential cause.In response to this incident, a notification has been sent to all applicable manufacturing personnel to raise awareness for this issue.Our quality team will closely monitor the production process for signs of this potential defect and any emerging trends.
 
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Brand Name
CONNECTA PLUS3 WHITE BLEND
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 Key10909627
MDR Text Key226253334
Report Number9610847-2020-00378
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 12/22/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/26/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date10/31/2020
Device Catalogue Number394900
Device Lot Number9305663
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/14/2020
Date Manufacturer Received12/22/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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