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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD ULTRA-FINE II SHORT NEEDLE INSULIN SYRINGE
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BD MEDICAL - DIABETES CARE BD ULTRA-FINE II SHORT NEEDLE INSULIN SYRINGE Back to Search Results
Catalog Number 328468
Device Problem Material Separation (1562)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/12/2018
Event Type  malfunction  
Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
 
Event Description
It was reported the bd ultra-fine ii short needle insulin syringe rubber stopper separated from the plunger rod before injection.There was no report of serious injury, blood exposure, or medical intervention.
 
Event Description
It was reported the bd ultra-fine ii short needle insulin syringe rubber stopper separated from the plunger rod before injection.There was no report of serious injury, blood exposure, or medical intervention.
 
Manufacturer Narrative
Investigation summary: customer returned loose 1/2cc insulin syringe.Customer states rubber stopper separated from plunger rod before injection.The returned syringe was examined and when trying to draw the plunger back, the stopper did not separate from the plunger; however, it was noticed the cannula was cloged as it was not able to aspirate.Device history record review ¿ a review of the device history record was completed for batch# 8099664.All inspections and challenges were performed per the applicable operations qc specifications.Syringe assembly ¿ there were three (3) batches of material# 700005657 (syringe 0.5ml asm 31g 8mm tw sm700178 sc) that went into the finished batch# 8099664.There were two (2) notifications [200751988, 200752964] noted that did not pertain to the complaint.Severity: s_1__; occurrence: a complaint history check was performed and this is the 1st related complaint reported for the defect/condition on lot number 8099664.Sample was forwarded to manufacturing (holdrege) on 2 november 2018 for further review.On 05nov2018, holdrege received one (1) loose 0.5ml, 8mm, 31g bd ultrafine ii syringe from batch# 8099664.All samples were decontaminated per hstr-17 and hqa-68 prior to being evaluated.Upon evaluation by qe ah, similar findings to those documented during initial investigation performed bd franklin lakes were noted.The returned sample was initially tested via wire gauge to verify results found in franklin lakes.The returned sample was unable to successfully be wire gauged, confirming a clog.The returned sample was then visually inspected under ultraviolet lighting with no additional defects or notable findings at that time.Probable root cause is adhesive blockage of the cannula, which failed to be removed during the manufacturing process on the needle lines.Generally, during the cannulation and curing of the adhesive, two (2) separate lumen blow systems are utilized to ensure potential clogs are removed from the fluid pathway.Based on the samples / photo(s) received the investigation concluded: confirmed: bd was able to duplicate or confirm the customer¿s indicated failure ¿ clog.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.
 
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Brand Name
BD ULTRA-FINE II SHORT NEEDLE INSULIN SYRINGE
Type of Device
INSULIN SYRINGE
Manufacturer (Section D)
BD MEDICAL - DIABETES CARE
1329 west highway 6
holdrege NE 68949
MDR Report Key8044540
MDR Text Key126514613
Report Number1920898-2018-00823
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 11/16/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/06/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date04/30/2023
Device Catalogue Number328468
Device Lot Number8099664
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/31/2018
Date Manufacturer Received10/12/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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