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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON BD ESR BI-LEVEL QC MATERIAL (4X8,5ML) ESR INSTRUMENT

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BECTON DICKINSON BD ESR BI-LEVEL QC MATERIAL (4X8,5ML) ESR INSTRUMENT Back to Search Results
Catalog Number 361555
Device Problem Incorrect, Inadequate or Imprecise Resultor Readings (1535)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/01/2020
Event Type  malfunction  
Manufacturer Narrative
The manufacturing location for this product is (b)(4). This site is an oem manufacturing site. Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number. Date of event: unknown. The date received by manufacturer has been used for this field. The reported lot# 195110 was not found for the catalog number. Device expiration date: n/a. Device manufacture date: unknown. 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 abnormal control occurred during use with a bd esr¿ bi-level qc material (4x8,5ml). The following information was provided by the initial reporter, "abnormal control of bottles was outside of the customer's defined 2s field. Original mail: i am writing to you regarding our bd sedi-40 device. We have recently received the new accu-sed plus controls (lot: 1945500-5). Now we have again the problem that the abnormal control (lot: 195110) is within the manufacturer's range but outside our 2s range. We have created several aliquots and mixed them well and always get a value of 42mm/hr (manufacturer's range 40-60mm/hr; target value of 50mm/hr). ".
 
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Brand NameBD ESR BI-LEVEL QC MATERIAL (4X8,5ML)
Type of DeviceESR INSTRUMENT
Manufacturer (Section D)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
Manufacturer (Section G)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
8015652341
MDR Report Key9982671
MDR Text Key189152643
Report Number2243072-2020-00636
Device Sequence Number1
Product Code GHC
Combination Product (y/n)N
Reporter Country CodeSZ
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 06/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/21/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number361555
Device Lot NumberSEE. H.10
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/13/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/01/2020
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

Patient Treatment Data
Date Received: 04/21/2020 Patient Sequence Number: 1
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