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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL¿ L CONNECTOR C90J SEE H.10.

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BECTON DICKINSON, S.A. BD PHASEAL¿ L CONNECTOR C90J SEE H.10. Back to Search Results
Catalog Number 515309
Device Problems Leak/Splash (1354); Defective Component (2292)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/22/2022
Event Type  malfunction  
Event Description
It was reported that the bd phaseal¿ l connector c90j membrane was separated and leaked. There was no report of patient impact. The following information was provided by the initial reporter, translated from (b)(6) to english: during preparation of an anticancer agent, the hcp disengaged the injector from the l-connector and then the membrane of the connector was separated, which resulted in leakage.
 
Manufacturer Narrative
Common device name: closed antineoplastic and hazardous drug reconstitution and transfer system. A device evaluation is anticipated but has not yet begun. Upon completion of the investigation, a supplemental report will be filed.
 
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Brand NameBD PHASEAL¿ L CONNECTOR C90J
Type of DeviceSEE H.10.
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
phillip emmert
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key13690213
MDR Text Key286744806
Report Number3003152976-2022-00092
Device Sequence Number1
Product Code ONB
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 Foreign,Health Professional,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 02/28/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/08/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number515309
Device Lot Number2109206
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/22/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/07/2021
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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