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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. NEEDLE WEISS 16GA 3-1/2IN ANESTHESIA CONDUCTION KIT

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BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. NEEDLE WEISS 16GA 3-1/2IN ANESTHESIA CONDUCTION KIT Back to Search Results
Catalog Number 408354
Device Problem Device Markings/Labelling Problem (2911)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/16/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(6). Investigation summary: our quality engineer was unable to verify the reported complaint. Photos or samples are not available for analysis and because no objective evidence of this issue was found during the analysis of the device history record and quality notifications for the claimed lot, it was not possible to verify this complaint as being generated by manufacturing process. A complaint history check was performed and this is the 1st related complaint reported with the defect/condition of mixed product / lots with lot #8207685 regarding item #(b)(4). A review of the device history record was completed for catalog #408381 lot 8207685 packed from 18-aug-18 to 24-aug-18 on the anesthesia line. The incorrect product was analyzed inside the unit packages and no records were found that could lead to the incident in question. Qn/ ncmr review: there are no quality notification (qn) or non-conformity report records of this issue, for the lot involved in this complaint. Investigation conclusion: unconfirmed: bd was not able to duplicate or confirm the customer's indicated failure mode for mixed product as no samples or photos were provided. Root cause description: based on the investigation results to date, the root cause was not determinate for this complaint since the defect was not confirmed. Rationale: complaints received for this device and the reported defect will continue to be tracked and trended. The information will be captured in the trend reports and monitored monthly. Collected data are regularly reviewed to identify emerging trends. Based on this, a capa is not needed at this time.
 
Event Description
It was reported that the newly unpackaged needle weiss 16ga 3-1/2in was measured as an 18 gauge rather than the labeled 16 gauge. As reported by the customer, translated from portuguese to english, "the nurse detected an adverse event when she opened the pack of 16, but when they opened the packaging they reported that the catheter was measuring 18 instead of 16 as reported on the package. ".
 
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Brand NameNEEDLE WEISS 16GA 3-1/2IN
Type of DeviceANESTHESIA CONDUCTION KIT
Manufacturer (Section D)
BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.
ave. pres.juscelino kubitschek
273 francisco bernardino
juiz de fora
Manufacturer (Section G)
BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.
ave. pres.juscelino kubitschek
273 francisco bernardino
juiz de fora
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
8015652341
MDR Report Key8383687
MDR Text Key137937697
Report Number9610048-2019-00125
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 02/20/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/01/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number408354
Device Lot Number8207685
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 Received02/18/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/31/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 03/01/2019 Patient Sequence Number: 1
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