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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 PLUS 3 WH W/O ENGAGEMENT STOP; STOPCOCK
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BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. CONNECTA PLUS 3 WH W/O ENGAGEMENT STOP; STOPCOCK Back to Search Results
Catalog Number 394906
Device Problem Leak/Splash (1354)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/18/2020
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 plus 3 wh w/o engagement stop had a loose connection with the syringe.This occurred on 2 occasions.The following information was provided by the initial reporter: the customer reported that the connection between this connecta and a syringe was loose.
 
Manufacturer Narrative
The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 12/21/2020.H.6.Investigation: a device history record review was completed by our quality engineer team for provided lot number 0010538.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 incident, two unused connecta sample products and additional syringe products were returned for evaluation by our quality engineer team.The syringe product provided by the customer did not ensure a reliable connection with the connecta product.This poor connection is due to the fact that the connecta product is designed for iso threaded type connections.The returned syringe product does not meet this requirement.
 
Event Description
It was reported that connecta plus 3 wh w/o engagement stop had a loose connection with the syringe.This occurred on 2 occasions.The following information was provided by the initial reporter: the customer reported that the connection between this connecta and a syringe was loose.
 
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Brand Name
CONNECTA PLUS 3 WH W/O ENGAGEMENT STOP
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 Key11103356
MDR Text Key227036366
Report Number9610847-2020-00445
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 02/09/2021
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 Date12/31/2022
Device Catalogue Number394906
Device Lot Number0010538
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/21/2020
Initial Date Manufacturer Received 12/03/2020
Initial Date FDA Received12/31/2020
Supplement Dates Manufacturer Received02/09/2021
Supplement Dates FDA Received02/17/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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