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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD ULTRA-FINE¿ NEEDLE

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BD MEDICAL - DIABETES CARE BD ULTRA-FINE¿ NEEDLE Back to Search Results
Catalog Number 328468
Device Problems Break (1069); Detachment Of Device Component (1104)
Patient Problem Foreign Body In Patient (2687)
Event Date 05/04/2018
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown.Medical device expiration date: unknown.Device manufacture date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation and/or device history review, a supplemental report will be filed.
 
Event Description
It was reported that the needle of a bd insulin syringe with the bd ultra-fine¿ needle broke off in the consumers stomach.The needle was removed without medical intervention.There was no report of exposure, injury or medical intervention.
 
Manufacturer Narrative
Investigation summary: customer returned one 1/2cc, 8mm, 31g syringe in an open poly bag from lot # 7352846.Customer states that the needle broke off in her stomach and had bruising on injection site and the syringes were clogged.The returned syringe was examined and no broken cannula was observed.The sample was tested for point geometry, lube, and cannula od (specs: outer diameter for 31g: 0.0100¿-0.0105¿).The point exhibited proper geometry, the od was measured as 0.0102¿, and sufficient lube was observed.The sample was also tested and was able to draw and expel properly without any observed defects.A review of the device history record was completed for batch# 7352846.All inspections and challenges were performed per the applicable operations qc specifications.There were eight notifications noted that did not pertain to the complaint.Based on the samples / photo(s) received the investigation concluded: unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure.Root cause cannot be determined at this time as the issue is unconfirmed.
 
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Brand Name
BD ULTRA-FINE¿ NEEDLE
Type of Device
NEEDLE
Manufacturer (Section D)
BD MEDICAL - DIABETES CARE
1329 west highway 6
holdrege NE 68949
MDR Report Key7534761
MDR Text Key109012954
Report Number1920898-2018-00353
Device Sequence Number1
Product Code FMF
UDI-Device Identifier00382908468039
UDI-Public00382908468039
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 05/25/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/22/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Catalogue Number328468
Device Lot NumberUNKNOWN
Date Manufacturer Received05/04/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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