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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
Model Number 515085
Medical Device Problem Code Leak/Splash (1354)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 07/29/2021
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that connector c35-o was loose.The following information was provided by the initial reporter: " it was reported: injector/connector separation, disconnection".
 
Additional Manufacturer Narrative
The customer's address is unknown.(b)(6).A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Medical device expiration date: unknown.Device manufacture date: unknown.
 
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Brand Name
CONNECTOR C35-O
Common Device Name
INTRAVASCULAR ADMINISTRATION SET
Manufacturer (Section D)
BECTON DICKINSON, S.A.
camino de valdeolivia
s/n
san agustin de guadalix
MDR Report Key12416598
Report Number3003152976-2021-00543
Device Sequence Number11663129
Product Code ONB
UDI-Device Identifier00382905150852
UDI-Public00382905150852
Combination Product (Y/N)N
Initial Reporter StateNJ
Initial Reporter CountryUS
PMA/510(K) Number
K181221
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source other,user facility
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 08/23/2021
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
Operator of Device Other
Device Model Number515085
Device Catalogue Number515085
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 08/04/2021
Initial Report FDA Received Date09/02/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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