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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL 30 ML BD LUER-LOK¿ TIP SYRINGE HYPODERMIC SYRINGE

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BD MEDICAL (BD WEST) MEDICAL SURGICAL 30 ML BD LUER-LOK¿ TIP SYRINGE HYPODERMIC SYRINGE Back to Search Results
Catalog Number 302832
Device Problems Contamination (1120); Device Contamination with Chemical or Other Material (2944)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/14/2017
Event Type  malfunction  
Manufacturer Narrative
Results: based on the photo(s) received the investigation concluded that bd was able to confirm the customer¿s indicated issue. Conclusion: complaints received for this device and reported condition will continue to be tracked and trended. Information will be captured on trend reports and monitored monthly. (b)(4).
 
Event Description
A pharmacy reported that contamination was found on a tip of a 30 ml bd luer-lok¿ tip syringe. Foreign matter was found prior to use. No injury or medical interventions reported.
 
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Brand Name30 ML BD LUER-LOK¿ TIP SYRINGE
Type of DeviceHYPODERMIC 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
brett wilko
9450 south state street
sandy, UT 84070
8015652845
MDR Report Key6751220
MDR Text Key81474221
Report Number1911916-2017-00175
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 consumer,other,user facility
Reporter Occupation
Type of Report Initial
Report Date 07/28/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/28/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date10/31/2021
Device Catalogue Number302832
Device Lot Number6278893
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/17/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/01/2016
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: 07/28/2017 Patient Sequence Number: 1
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