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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
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BD MEDICAL - DIABETES CARE BD ULTRA-FINE INSULIN SYRINGE Back to Search Results
Catalog Number 329416
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 03/23/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: n/a.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
 
Event or Problem Description
It was reported during use of the bd ultra-fine insulin syringe the syringe is leaking.The consumer reported ¿when drawing insulin into the syringe, insulin leaks around needle hub.Stated it happened with five syringes.¿ there was no report of injury or medical intervention.
 
Additional Manufacturer Narrative
Correction: it was found that this complaint is a duplicate of complaint pr # 312628 mfg # 1920898-2018-00173.Please see supplemental mdr # 368306 for the device evaluation report.
 
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Brand Name
BD ULTRA-FINE INSULIN SYRINGE
Common Device Name
INSULIN SYRINGE
Manufacturer (Section D)
BD MEDICAL - DIABETES CARE
1329 west highway 6
holdrege NE 68949
MDR Report Key7396503
Report Number1920898-2018-00226
Device Sequence Number13758303
Product Code FMF
UDI-Device Identifier00382903294169
UDI-Public00382903294169
Combination Product (Y/N)N
Initial Reporter StateCO
Initial Reporter CountryUS
PMA/510(K) Number
K170386
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source consumer,other
Initial Reporter Occupation Patient
Type of Report Initial,Followup
Report Date (Section B) 04/26/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Operator of Device Lay User/Patient
Device Catalogue Number329416
Device Lot Number7241532
Initial Date Received by Manufacturer 03/23/2018
Supplement Date Received by Manufacturer03/23/2018
Initial Report FDA Received Date04/04/2018
Supplement Report FDA Received Date04/26/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
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