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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD INSULIN SYRINGE W/ BD ULTRA-FINE¿ NEEDLE; INSULIN SYRINGE AND NEEDLE
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BD MEDICAL - DIABETES CARE BD INSULIN SYRINGE W/ BD ULTRA-FINE¿ NEEDLE; INSULIN SYRINGE AND NEEDLE Back to Search Results
Catalog Number 328418
Device Problem Positioning Failure (1158)
Patient Problem Pain (1994)
Event Date 04/17/2018
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.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 with the use of the bd insulin syringe w/ bd ultra-fine¿ needle there was an issue with difficult plunger movement/needle pain.It was stated ¿there were 3 syringes that were extremely hard to push the plunger while injecting.They seemed loose when the consumer pulled to select air amount and a little stiff when injecting air.Once the consumer started injecting it was really hard to push the plunger and it hurt when the consumer tried to push hard enough to inject.¿ there was no report of injury or further medical intervention.
 
Manufacturer Narrative
Investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.Complaints received for this device and reported condition will continue to be tracked and trended.If samples are received in the future the complaint will be reopened for further investigation.A review of the device history record was completed for batch# 7282967.All inspections were performed per the applicable operations qc specifications.Based on the samples / photo(s) received the investigation concluded: unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure as no samples or photos were returned.
 
Manufacturer Narrative
Investigation summary: customer returned (26) loose 1cc, 8mm, 31g syringes.Customer states that the plunger rod is difficult to push causing needle pain.All returned syringes were examined and 22 out of 26 samples exhibited the cannula clipped off.All remaining samples were tested for point geometry, lube, and cannula od.The following was observed (specs: outer diameter for 31g: 0.0100¿-0.0105¿): data: point outer diameter (in) lube sample 1; good; 0.0101; good; sample 2; good; 0.0101; good; sample 3; good; 0.0102; good; sample 4; good; 0.0102; good.All samples were teste and all plungers were able to be exercised in the barrel without any observed defects.A review of the device history record was completed for batch#: 7282967.All inspections were performed per the applicable operations qc specifications.There were five (5) notifications [200721801, 200721848, 200721724, 200721273, 200722263] noted that did not pertain to the complaint.Severity: s_2__; occurrence: a complaint history check was performed and this is the 1st related complaint for plunger difficult to move and the 1st related complaint or needle pain on lot#: 7282967.Based on the samples / photo(s) received the investigation concluded: unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure.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.Based on the above, no additional investigation and no capa is required at this time.
 
Event Description
It was reported with the use of the bd insulin syringe w/ bd ultra-fine¿ needle there was an issue with difficult plunger movement/needle pain.It was stated ¿there were 3 syringes that were extremely hard to push the plunger while injecting.They seemed loose when the consumer pulled to select air amount and a little stiff when injecting air.Once the consumer started injecting it was really hard to push the plunger and it hurt when the consumer tried to push hard enough to inject.¿ there was no report of injury or further medical intervention.
 
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Brand Name
BD INSULIN SYRINGE W/ BD ULTRA-FINE¿ NEEDLE
Type of Device
INSULIN SYRINGE AND NEEDLE
Manufacturer (Section D)
BD MEDICAL - DIABETES CARE
1329 west highway 6
holdrege NE 68949
MDR Report Key7475832
MDR Text Key107196702
Report Number1920898-2018-00303
Device Sequence Number1
Product Code FMF
UDI-Device Identifier00382908418034
UDI-Public00382908418034
Combination Product (y/n)N
PMA/PMN Number
K170386
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Type of Report Initial,Followup,Followup
Report Date 11/08/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/01/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date10/31/2022
Device Catalogue Number328418
Device Lot Number7282967
Date Manufacturer Received04/17/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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