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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD 60ML SYRINGE LUER-LOK TIP PISTON SYRINGE

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BD MEDICAL (BD WEST) MEDICAL SURGICAL BD 60ML SYRINGE LUER-LOK TIP PISTON SYRINGE Back to Search Results
Catalog Number 302827
Device Problem Fungus in Device Environment (2316)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/12/2020
Event Type  malfunction  
Manufacturer Narrative
Investigation summary: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident. No root cause can be determined as no samples were received. Examination of the product involved may provide clarification as to the cause for the reported failure. 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. Our business team regularly reviews the collected data for identification of emerging trends. Based on no sample, the investigation concluded, bd was not able to verify the indicated failure. Investigation conclusion: this is the 2nd complaint for lot # 9009885 for this type of defect or symptom. Previous complaint (b)(4). There was no documentation for this type of defect during the entire production run of this batch. Root cause description: undetermined. Rationale: capa not required at this time.
 
Event Description
It was reported that prior to use mold was discovered on the top of plunger with a bd 60ml syringe luer-lok¿ tip. The following information was provided by the initial reporter, translated from (b)(6) to english: during one of our processes, we noticed that (before opening the package) a 60 ml syringe unit had dirt on the top of the plunger, appearing to be mold.
 
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Brand NameBD 60ML SYRINGE LUER-LOK TIP
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
brett wilko
9450 south state street
sandy, UT 84070
8015652341
MDR Report Key9739385
MDR Text Key188405337
Report Number1911916-2020-00175
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 02/17/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/21/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number302827
Device Lot Number9009885
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 Received02/14/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/09/2019
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: 02/21/2020 Patient Sequence Number: 1
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