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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD CARIBE LTD. BD PERISAFE¿ KITS ANESTHESIA CONDUCTION KIT

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BD CARIBE LTD. BD PERISAFE¿ KITS ANESTHESIA CONDUCTION KIT Back to Search Results
Model Number 400273
Device Problem Component Missing (2306)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/24/2021
Event Type  malfunction  
Manufacturer Narrative
Initial reporter phone #: (b)(6). 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 2 bd perisafe¿ kits experienced device damage while still considered operable. The following information was provided by the initial reporter: filter is missing in bd perisafe kit ( 2 units).
 
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Brand NameBD PERISAFE¿ KITS
Type of DeviceANESTHESIA CONDUCTION KIT
Manufacturer (Section D)
BD CARIBE LTD.
road 31
k.m. 24.3
juncos
Manufacturer (Section G)
BD CARIBE LTD.
road 31
k.m. 24.3
juncos
Manufacturer Contact
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key12675867
MDR Text Key278118006
Report Number2618282-2021-00060
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
K953790
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,Followup
Report Date 04/13/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/21/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number400273
Device Catalogue Number400273
Device Lot Number0281597
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/11/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/13/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/09/2020
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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