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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD CARIBE LTD. KIT PERISAFE 18GA 3-1/2IN WEISS ANESTHESIA CONDUCTION KIT

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BD CARIBE LTD. KIT PERISAFE 18GA 3-1/2IN WEISS ANESTHESIA CONDUCTION KIT Back to Search Results
Model Number 400273
Device Problem Volume Accuracy Problem (1675)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/05/2021
Event Type  malfunction  
Manufacturer Narrative
Medical device expiration date: unknown. Device manufacture date: unknown. Investigation summary: no photos or samples were received by our quality team for evaluation therefore the failure mode could not be verified and the root cause could not be determined. A device history record could not be evaluated as the lot number is unknown. A photo of the defect could assist our quality team in their investigation. Examination of the product involved may provide clarification as to the cause for the reported failure.
 
Event Description
It was reported that 10 kit perisafe 18ga 3-1/2in weiss had a scale marking issue. The following information was provided by the initial reporter: "the black mark on the catheter comes off on contact with the skin disinfectant (desderman, sterilium and kodan forte were tested). Without the marking, the user can no longer see how far the catheter must be inserted or whether the catheter has been completely removed, and it can lead to complications. ".
 
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Brand NameKIT PERISAFE 18GA 3-1/2IN WEISS
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 Key11926426
MDR Text Key256048341
Report Number2618282-2021-00030
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Reporter Country CodeGM
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
Report Date 02/02/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/02/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number400273
Device Catalogue Number400273
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/01/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/02/2022
Was Device Evaluated by Manufacturer? Yes
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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