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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE RELION INSULIN SYRINGE PISTON SYRINGE

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BD MEDICAL - DIABETES CARE RELION INSULIN SYRINGE PISTON SYRINGE Back to Search Results
Model Number 328509
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hypersensitivity/Allergic reaction (1907); Pain (1994); Local Reaction (2035); Burning Sensation (2146)
Event Date 04/28/2020
Event Type  Injury  
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used for this field. Investigation summary: customer returned samples from lot # 9154593 which will be investigated under complaint (b)(4). No samples (including photos) were returned from lot # 9210536 therefore the complaint could not be confirmed and the root cause is undetermined. Complaints received for this device and reported condition will continue to be tracked and trended. If samples are received in the future the complaint will be reopened for further investigation. A review of the device history record was completed for batch# 9210536. All inspections and challenges were performed per the applicable operations qc specifications. There was one (1) notification [200837053] noted that did not pertain to the complaint. Conclusion: as no samples and/or photo(s) were received the investigation concluded: unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure as no samples or photos were returned. Root cause: root cause cannot be determined at this time as the issue is unconfirmed as no samples or photos were returned. Rationale: based on the above, no additional investigation and no capa is required at this time.
 
Event Description
It was reported during use the relion® insulin syringe the consumer experienced serious injury (medical intervention). The following information was provided by the initial reporter: the customer may have experienced an allergic reaction to relion syringes. Consumer stated that there is pain/burning at the injection site during injection, said it happens when she inserts the needle, just before she releases the insulin. Also stated that sores developed around the injection site after injection. Consumer stated that she noticed the burning over the years but it seemed to have gotten much worse a few months ago when she had a surgery to have metal plates and screws put in her neck. Consumer was prescribed medication (levocetirine and something else) to relieve the pain and clear up the sores.
 
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Brand NameRELION INSULIN SYRINGE
Type of DevicePISTON 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
8015652341
MDR Report Key10074991
MDR Text Key191799776
Report Number1920898-2020-00548
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K024112
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Reporter Occupation
Type of Report Initial
Report Date 04/29/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/20/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number328509
Device Catalogue Number328509
Device Lot Number9210536
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/28/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/11/2019
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: 05/20/2020 Patient Sequence Number: 1
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