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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¿ 3-WAY STOPCOCK
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BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD CONNECTA¿ 3-WAY STOPCOCK Back to Search Results
Catalog Number 394602
Device Problems Crack (1135); Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/10/2022
Event Type  malfunction  
Event Description
It was reported that the bd connecta¿ 3-way stopcock was cracked and caused medication to leak out into the patient's sheets during the infusion.The following information was provided by the initial reporter, translated from chinese: "on (b)(6) 2022, the patient underwent intravenous infusion during postoperative observation.During the infusion, the bed sheet of the patient was wet, and it was found that the connecta (specification model: 394602; product change number batch number: 2032537) had cracks and caused liquid ooze.After switching to another batch of connecta, the infusion activities can be carried out normally, and this adverse event is reported.".
 
Manufacturer Narrative
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¿ 3-way stopcock was cracked and caused medication to leak out into the patient's sheets during the infusion.The following information was provided by the initial reporter, translated from chinese: "on (b)(6) 2022, the patient underwent intravenous infusion during postoperative observation.During the infusion, the bed sheet of the patient was wet, and it was found that the connecta (specification model: 394602; product change number batch number: 2032537) had cracks and caused liquid ooze.After switching to another batch of connecta, the infusion activities can be carried out normally, and this adverse event is reported.".
 
Manufacturer Narrative
H6: investigation summary no photos or samples were received by our quality team for evaluation therefore the failure mode could not be verified.A review of the internal manufacturing device records and raw material history files for the reported lot number was performed and no recorded quality problems or rejections to this incident were found.Based on the quality team's investigation, the root cause of this incident cannot be determined.The device history records (dhr) review was performed for the lot number material identified in this complaint.According to the documented records, the product was manufactured according to the approved manufacturing procedures, specifications, and then released by quality assurance.
 
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Brand Name
BD CONNECTA¿ 3-WAY 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
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key15971588
MDR Text Key307703549
Report Number9610847-2022-00469
Device Sequence Number1
Product Code FMG
Combination Product (y/n)N
Reporter Country CodeCH
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 12/15/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/13/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number394602
Device Lot Number2032537
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/15/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/28/2022
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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