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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD LUER-LOK TIP SYRINGE PISTON SYRINGE

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BD MEDICAL (BD WEST) MEDICAL SURGICAL BD LUER-LOK TIP SYRINGE PISTON SYRINGE Back to Search Results
Model Number 302830
Device Problem Fungus in Device Environment (2316)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/11/2021
Event Type  malfunction  
Manufacturer Narrative
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 mold was found in the unopened bd luer-lok¿ tip syringe. The following information was provided by the initial reporter: "the pharmacist called stating tha the encountered mold inside an unopened syringe".
 
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Brand NameBD LUER-LOK TIP SYRINGE
Type of DevicePISTON SYRINGE
Manufacturer (Section D)
BD MEDICAL (BD WEST) MEDICAL SURGICAL
1852 10th avenue
columbus NE 68601
Manufacturer (Section G)
BD MEDICAL (BD WEST) MEDICAL SURGICAL
1852 10th avenue
columbus NE 68601
Manufacturer Contact
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key12450072
MDR Text Key270799220
Report Number1911916-2021-00971
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K110771
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Reporter Occupation Pharmacist
Type of Report Initial
Report Date 08/26/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/09/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number302830
Device Catalogue Number302830
Device Lot Number1113457
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 Received08/12/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/23/2021
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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