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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD INSULIN SYRINGE WITH BD ULTRA-FINE¿ NEEDLE; PISTON SYRINGE
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BD MEDICAL - DIABETES CARE BD INSULIN SYRINGE WITH BD ULTRA-FINE¿ NEEDLE; PISTON SYRINGE Back to Search Results
Catalog Number 328418
Device Problems Difficult to Remove (1528); No Flow (2991)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/18/2018
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown.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 that during use of the bd insulin syringe with bd ultra-fine¿ needle, during injection, insulin does not come out of syringe.Consumer also stated that with some syringes, the plunger rod is difficult to move during the injection and before the injection.There was no report of exposure, serious injury or medical intervention.
 
Event Description
It was reported that during use of the bd insulin syringe with bd ultra-fine¿ needle, during injection, insulin does not come out of syringe.Consumer also stated that with some syringes, the plunger rod is difficult to move during the injection and before the injection.There was no report of exposure, serious injury or medical intervention.
 
Manufacturer Narrative
Correction: due to an it issue beginning on 7/3/2018, previously filed emdrs did not contain required fields.This supplemental emdr is filed to provide the following omitted fields: event attributed to: other.Device single use?: no.Device returned to manufacturer: no.
 
Manufacturer Narrative
H.6.- complaint evaluation / complaint history check for the event(s) that occurred.A complaint history check was performed and this is the 1st related complaint for difficult/unable to operate and plunger rod difficult to move on lot # 7219705.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# 7219705.All inspections were performed per the applicable operations qc specifications.There were two (2) notifications [200709105, 200708576] noted that did not pertain to the complaint.There was one (1) notification [200708781] noted for smeared stoppers.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.Based on the above, no additional investigation and no capa is required at this time root cause cannot be determined at this time as the issue is unconfirmed as no samples or photos were returned.Based on the investigation, no additional investigation and no capa is required at this time.
 
Event Description
It was reported that during use of the bd insulin syringe with bd ultra-fine¿ needle, during injection, insulin does not come out of syringe.Consumer also stated that with some syringes, the plunger rod is difficult to move during the injection and before the injection.There was no report of exposure, serious injury or medical intervention.
 
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Brand Name
BD INSULIN SYRINGE WITH BD ULTRA-FINE¿ NEEDLE
Type of Device
PISTON SYRINGE
Manufacturer (Section D)
BD MEDICAL - DIABETES CARE
1329 west highway 6
holdrege NE 68949
MDR Report Key7758596
MDR Text Key116542530
Report Number1920898-2018-00605
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 08/16/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/07/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Catalogue Number328418
Device Lot Number7219705
Date Manufacturer Received07/18/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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