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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
Model Number 328440
Device Problem Volume Accuracy Problem (1675)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/12/2022
Event Type  malfunction  
Event Description
It was reported that the bd insulin syringe with bd ultra-fine¿ needle scale markings are crooked on the syringe barrel.The following information was provided by the initial reporter: "consumer reported she's finding syringes prior to use with crooked scale markings.Stated, the first line on the barrel is in different starting point from syringe to syringe.Stated, the first unit marking can be all the way to the top or further away from the top.".
 
Manufacturer Narrative
Date of event: unknown.The original 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 that the bd insulin syringe with bd ultra-fine¿ needle scale markings are crooked on the syringe barrel.The following information was provided by the initial reporter: "consumer reported she's finding syringes prior to use with crooked scale markings.Stated, the first line on the barrel is in different starting point from syringe to syringe.Stated, the first unit marking can be all the way to the top or further away from the top.".
 
Manufacturer Narrative
The following fields were updated due to additional information: d.10.Device available for eval: yes.D.10.Returned to manufacturer on: 31-may-2022.H.6.Investigation summary: a complaint lot history check was performed on lot # 1228476 for scale misaligned.This is the 1st related complaint for scale misaligned on lot # 1228476.Customer returned (41) 0.3ml, 30 gauge, 8mm syringes from lot 1228476.30 of the syringes were inspected via gauge to ensure correct placement of the graduation markings.6 of the inspected samples were found to have graduation markings printed lower than intended at the 5 unit mark.All other samples found to be within permitted specifications.A review of the device history record was completed for batch # 1228476 all inspections were performed per the applicable operations qc specifications.Based on the samples received, embecta was able to confirm the customer¿s indicated failure of misaligned scales in 6 of 30 measured samples.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 returned sample analysis from complaint handling department 30 of the syringes were inspected via gauge to ensure correct placement of the graduation markings.6 of the inspected samples were found to have graduation markings printed lower than intended at the (b)(4) unit mark.All other samples found to be within permitted specifications.Did not find any l2l (leading to lean) maintenance dispatch history.Root-cause for scale-mark misaligned caused due to lose bolts on brass roller on cz printer and air jet got displaced from it's position.Lose bolts on brass roller on cz printer has been tightened.Air jet on the printer got repaired.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.H3 other text : see h.10.
 
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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
Manufacturer (Section G)
BD MEDICAL - DIABETES CARE
1329 west highway 6
holdrege NE 68949
Manufacturer Contact
phillip emmert
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key14493190
MDR Text Key292586158
Report Number1920898-2022-00360
Device Sequence Number1
Product Code FMF
UDI-Device Identifier00382908440035
UDI-Public00382908440035
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K190054
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 06/28/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/25/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number328440
Device Catalogue Number328440
Device Lot Number1228476
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Manufacturer Received06/28/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/16/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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