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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 7 CM WHITE BLEND; STOPCOCK
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BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. CONNECTA PLUS3 7 CM WHITE BLEND; STOPCOCK Back to Search Results
Catalog Number 394945
Device Problem Infusion or Flow Problem (2964)
Patient Problem No Patient Involvement (2645)
Event Date 10/13/2020
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.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 7 cm white blend tubing was kinked.This occurred on 50 occasions.The following information was provided by the initial reporter: as can be seen in the appendix, there is a kink in the hose.When checking the other 50 pieces of packages, several pieces in each package are affected! request for replacement of the goods!.
 
Event Description
It was reported that connecta plus3 7 cm white blend tubing was kinked.This occurred on 50 occasions.The following information was provided by the initial reporter: as can be seen in the appendix, there is a kink in the hose.When checking the other 50 pieces of packages, several pieces in each package are affected! request for replacement of the goods!.
 
Manufacturer Narrative
H.6.Investigation: to aid in the investigation of this incident, picture samples were provided for evaluation by our quality engineer team.Through examination of the pictures, the tubing was observed kinked.A device history record review was performed for provided lot number 9309923.Part of this lot was involved with a non-conformance related to tubing length out of specification.It is possible for incorrect tubing length to result in kinked tubing.
 
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Brand Name
CONNECTA PLUS3 7 CM 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 Key10795272
MDR Text Key219380379
Report Number9610847-2020-00342
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
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date10/31/2022
Device Catalogue Number394945
Device Lot Number9309923
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 10/13/2020
Initial Date FDA Received11/05/2020
Supplement Dates Manufacturer Received11/24/2020
Supplement Dates FDA Received12/02/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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