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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON EMERALD SYRINGE 2ML 24X1 AN

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BECTON DICKINSON EMERALD SYRINGE 2ML 24X1 AN Back to Search Results
Catalog Number 307749
Device Problem Volume Accuracy Problem (1675)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/02/2021
Event Type  malfunction  
Manufacturer Narrative
Oem manufacture: 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) 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. Investigation summary: no samples (including photos) were returned for the reported issue of ¿in emerald fw 2ml 24 printing was missing¿ with lot number 1126021 regarding item # 307749, so retention samples were used for the investigation. The dhr of material number 307749 and lot number 1126021 was checked and no quality notifications were recorded on this lot. None of the ten retention samples showed printing missing on them. The defect could not be confirmed. As no photographs or original samples available for investigation the defect cannot be confirmed. Based on the above, no additional investigation and no capa is required at this time. Investigation conclusion: no samples and no photographs were received from the customer. The investigation team have used retention samples of material code 307749 and lot number 1126021 for investigating the reported defect of printing mistake in the lab. None of the 10 retention samples showed printing missing on them. The defect could not be confirmed. As no photographs or original samples available for investigation of the printing mistake as reported by the customer the defect cannot be confirmed. Complaints received for this device and reported condition will continue to be tracked and trended. If samples are received in the future the complaint will be reopened for further investigation.
 
Event Description
It was reported that 2,000 emerald syringe 2ml 24x1 an experienced missing scale marking. The following information was provided by the initial reporter: in emerald fw 2ml 24 printing was missing.
 
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Brand NameEMERALD SYRINGE 2ML 24X1 AN
Type of DeviceSYRINGE
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
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key12556004
MDR Text Key274256990
Report Number2243072-2021-02421
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
NA
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
Report Date 09/14/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/30/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number307749
Device Lot Number1126021
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 Received09/02/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/06/2021
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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