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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
Catalog Number 328512
Device Problem Leak/Splash (1354)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/03/2020
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used.Medical device expiration date: na.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 that the needle hub separated from the relion® insulin syringe and remained in the shield.The following information was provided by the initial reporter: "consumer reported needle hub separated and stayed inside of the shield.".
 
Manufacturer Narrative
H6: investigation summary: this complaint is a duplicate of mfr#: 1920898-2020-01786.Information pertaining to this complaint, 1920898-2020-01785, has been captured in 1920898-2020-01786.Mfr#: 1920898-2020-01785 is void as a result.
 
Event Description
It was reported that the needle hub separated from the relion® insulin syringe and remained in the shield.The following information was provided by the initial reporter: "consumer reported needle hub separated and stayed inside of the shield.".
 
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Brand Name
RELION INSULIN SYRINGE
Type of Device
PISTON SYRINGE
Manufacturer (Section D)
BD MEDICAL - DIABETES CARE
1329 west highway 6
holdrege NE 68949
MDR Report Key11103502
MDR Text Key225826137
Report Number1920898-2020-01785
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
PMA/PMN Number
K024112
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Type of Report Initial,Followup
Report Date 03/26/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/31/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Catalogue Number328512
Device Lot Number0098920
Was Device Available for Evaluation? No
Date Manufacturer Received03/26/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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