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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON, S.A. CONNECTOR C35-O INTRAVASCULAR ADMINISTRATION SET

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BECTON DICKINSON, S.A. CONNECTOR C35-O INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Catalog Number 515070
Device Problem Disconnection (1171)
Patient Problem Chemical Exposure (2570)
Event Date 09/02/2021
Event Type  malfunction  
Manufacturer Narrative
Medical device expiration date: unknown. Device manufacture date: unknown. Investigation summary: no photos or physical samples that display the reported condition were available for investigation. Product undergoes inspections throughout the manufacturing process to ensure the quality and functionality of the device. As the lot involved in this incident is unknown, a device history review cannot be performed, and additional retained samples cannot be evaluated. Based on the available information we are not able to identify a root cause at this time. Complaints received for this device and reported condition will continue to be tracked and trended. Our quality team regularly reviews the collected data for identification of emerging trends.
 
Event Description
It was reported that connector c35-o separation from the luer mating component. The following information was provided by the initial reporter: connector unluered off cadd pump while patient was sleeping. Email response: can you please provide additional details in regards to the issue? i do not have any more information at this time. Can you please provide the lot number? i was not provided the lot #. Can you please provide the material number? i was not provided the material #. Can you please provide the date of event? (b)(6) 2021. Would you happen to have photos you can share? i do not have any photos would you happen to have samples to return? if so, we will send a fedex pre-paid label to return samples. Please provide a direct address and phone. I was not given the connector. Was there an exposure to blood or medicines? the patient was exposed to chemo if exposure to blood or medicines what was the route of exposure? who was exposed, the healthcare provider or the patient? the patient was exposed at night while they were sleeping.
 
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Brand NameCONNECTOR C35-O
Type of DeviceINTRAVASCULAR ADMINISTRATION SET
Manufacturer (Section D)
BECTON DICKINSON, S.A.
camino de valdeolivia
s/n
san agustin de guadalix
Manufacturer (Section G)
BECTON DICKINSON, S.A.
camino de valdeolivia
s/n
san agustin de guadalix
Manufacturer Contact
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key12600067
MDR Text Key278604460
Report Number3003152976-2021-00674
Device Sequence Number1
Product Code ONB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K181221
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 09/21/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/08/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number515070
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/10/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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