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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD¿ 50 ML CATHETER TIP SYRINGE

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BD MEDICAL (BD WEST) MEDICAL SURGICAL BD¿ 50 ML CATHETER TIP SYRINGE Back to Search Results
Catalog Number 303553
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/17/2021
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 the bd¿ 50 ml catheter tip syringe experienced foreign matter along the fluid path. The following information was provided by the initial reporter: sterile syringe on opening. It was verified that there was dirt in the nozzle.
 
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Brand NameBD¿ 50 ML CATHETER TIP SYRINGE
Type of DeviceSYRINGE
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 Key12675215
MDR Text Key277731772
Report Number1911916-2021-01098
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
NA
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 10/28/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/21/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number303553
Device Lot Number0294724
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/28/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/20/2020
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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