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U.S. Department of Health and Human Services

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

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BD MEDICAL - DIABETES CARE RELION® INSULIN SYRINGE Back to Search Results
Catalog Number 328507
Device Problems Component Missing (2306); Device Markings/Labelling Problem (2911); Manufacturing, Packaging or Shipping Problem (2975)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/08/2018
Event Type  malfunction  
Manufacturer Narrative
Medical device expiration date: n/a. A device evaluation and/or device history review is anticipated, but is not complete. Upon completion, a supplemental report will be filed.
 
Event Description
It was reported that relion® insulin syringe was missing the safety shield, missing the needle, scale markings were illegible, and had an incorrect quantity of products in packaging. No serious injury or medical intervention was reported.
 
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Brand NameRELION® INSULIN SYRINGE
Type of DeviceINSULIN 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 Key7806708
MDR Text Key118002426
Report Number1920898-2018-00659
Device Sequence Number1
Product Code FMF
UDI-Device Identifier00681131311649
UDI-Public00681131311649
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K941657
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Reporter Occupation Pharmacist
Type of Report Initial,Followup
Report Date 08/27/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/22/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number328507
Device Lot Number7226729
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 Received08/07/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/12/2017
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: 08/22/2018 Patient Sequence Number: 1
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