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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD ULTRA-FINE¿ INSULIN SYRINGE 31 G X 6 MM INSLIN SYRINGE

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BD MEDICAL - DIABETES CARE BD ULTRA-FINE¿ INSULIN SYRINGE 31 G X 6 MM INSLIN SYRINGE Back to Search Results
Catalog Number 324918
Device Problem Insufficient Information (3190)
Patient Problems Erythema (1840); Itching Sensation (1943); No Code Available (3191)
Event Date 07/24/2017
Event Type  Injury  
Manufacturer Narrative
Results: a complaint history check was performed and this is the 1st related complaint reported for the defect/condition on lot number 5201563. Investigation summary: customer returned photos of red marks on the body. No photos of the product in question were returned by the customer. Customer states that the use of the product promoted papule formation in the application site, moreover the region got reddish and it caused itching. As per manufacturing, there were zero (0) defects or notifications noted for any defects during the production of these batches. Also, no issues with sterility were noted on the reported lot number. Based on the samples / photo(s) received the investigation concluded: unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure as none of the records from manufacturing indicate any issues with the product. 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 the above, no additional investigation and no capa is required at this time. Conclusion: bd was not able to duplicate or confirm the customer¿s indicated failure as none of the records from manufacturing indicate any issues with the product. 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.
 
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used for this field. (b)(6). A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed. (b)(4).
 
Event Description
It was reported the customer complained of papule, itching and redness at the injection site with a bd ultra-fine¿ insulin syringe 31 g x 6 mm. No medical interventions provided.
 
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Brand NameBD ULTRA-FINE¿ INSULIN SYRINGE 31 G X 6 MM
Type of DeviceINSLIN SYRINGE
Manufacturer (Section D)
BD MEDICAL - DIABETES CARE
1329 west highway 6
holdrege NE 68949
Manufacturer (Section G)
BD MEDICAL - DIABETES CARE
1329 west highway 6
holdrege NE 68949
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
8015652845
MDR Report Key6804714
MDR Text Key113286999
Report Number1920898-2017-00111
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
K024112
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Reporter Occupation Patient Family Member or Friend
Type of Report Initial,Followup
Report Date 10/03/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/18/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/31/2020
Device Catalogue Number324918
Device Lot Number5201563
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 Received07/24/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/20/2015
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: 08/18/2017 Patient Sequence Number: 1
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