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U.S. Department of Health and Human Services

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

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BD MEDICAL (BD WEST) MEDICAL SURGICAL 30ML BD SYRINGE WITH BD LUER-LOK¿ TIP, BULK, NON-STERILE HYPODERMIC SYRINGE Back to Search Results
Catalog Number 301033
Device Problem Contamination (1120)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/17/2017
Event Type  malfunction  
Manufacturer Narrative
Results: a sample was not returned for evaluation. A review of the device history record could not be performed as a lot number was not provided for this incident. In the event that new, changed, or corrected information is obtained, a supplemental report will be filed. Conclusion: without a sample, an absolute root cause for this incident cannot be determined as bd was not able to duplicate or confirm the customer¿s indicated failure mode. (b)(4).
 
Event Description
It was reported by a consumer that two packs of 30 ml bd luer-lok¿ syringe appeared to have condensation on them. The customer discarded the packs due to concerns with contamination. The condensation was found prior to use. No injury or medical interventions reported.
 
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Brand Name30ML BD SYRINGE WITH BD LUER-LOK¿ TIP, BULK, NON-STERILE
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 Key6749661
MDR Text Key81395539
Report Number1911916-2017-00101
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 Catalogue Number301033
Device Lot NumberUNKNOWN
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 Received05/25/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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