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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. BD CONNECTA¿ PLUS STOPCOCK
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BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD CONNECTA¿ PLUS STOPCOCK Back to Search Results
Catalog Number 394900
Device Problem Contamination (1120)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/14/2023
Event Type  malfunction  
Manufacturer Narrative
H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
 
Event Description
It was reported that the bd connecta¿ plus stopcock experienced foreign matter in fluid pathway.The following information was provided by the initial reporter, translated from japanese to english: this report is about dirt on the product.While priming with saline solution, dirt on the handle part was found.
 
Manufacturer Narrative
H.6.Investigation summary: it was reported there was dirt on the unit received.To aid in the investigation, one sample and six photos were provided for evaluation by our quality team.A visual inspection was performed and there is embedded foreign matter in the tap of the connecta product.Bd was also able to confirm the defect in the photos.This defect is related to the molding process of the components.A device history record review was completed for provided material number 394900, lot 2285640.According to the documented records, the product was manufactured according to the approved manufacturing procedures, specifications, and then released by quality assurance.There were no nonconformance(s), capas or abnormal conditions noted at the time of production.At the time of the dhr review, there were no changes to the process and/or equipment that would have affected the manufacturing of the device.Maintenance records were evaluated, and no problems were found.To date, there have been no other similar events reported for this lot.Based on the investigation, bd was able to confirm the customer¿s indicated failure mode but is attributed to the molding process.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.
 
Event Description
It was reported that the bd connecta¿ plus stopcock experienced foreign matter in fluid pathway.The following information was provided by the initial reporter, translated from japanese to english: this report is about dirt on the product.While priming with saline solution, dirt on the handle part was found.
 
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Brand Name
BD CONNECTA¿ PLUS STOPCOCK
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 
Manufacturer (Section G)
BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
periferico luis donaldo
colosio no. 579
nogales
MX  
Manufacturer Contact
phillip emmert
5859 farinon drive
san antonio, TX 78249
8448235433
MDR Report Key17293078
MDR Text Key319400842
Report Number9610847-2023-00172
Device Sequence Number1
Product Code FMG
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 08/07/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/10/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number394900
Device Lot Number2285640
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/26/2023
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/07/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/10/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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