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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 0.3ML 31GA 8MM HALFUNIT 10BG 500; PISTON SYRINGE
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BD MEDICAL - DIABETES CARE SYRINGE 0.3ML 31GA 8MM HALFUNIT 10BG 500; 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 07/19/2021
Event Type  malfunction  
Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
 
Event Description
It was reported that syringe 0.3ml 31ga 8mm halfunit 10bg 500 was missing scale markings.This occurred on 6 occasions.The following information was provided by the initial reporter: the customer complained that some of the scale on the syringe is missing.
 
Manufacturer Narrative
H6: investigation summary customer returned (6) loose 3/10cc, 8mm syringes.Customer states that some of the scale on the syringe is missing.All returned syringes were examined and all exhibited missing scale markings from the 0-5 unit markings.A review of the device history record was completed for batch# 0293915.All inspections and challenges were performed per the applicable operations qc specifications.There was one (1) notification noted that did not pertain to the complaint.Confirmed: bd was 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.H3 other text : see h10.
 
Event Description
It was reported that syringe 0.3ml 31ga 8mm halfunit 10bg 500 was missing scale markings.This occurred on 6 occasions.The following information was provided by the initial reporter: the customer complained that some of the scale on the syringe is missing.
 
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Brand Name
SYRINGE 0.3ML 31GA 8MM HALFUNIT 10BG 500
Type of Device
PISTON SYRINGE
Manufacturer (Section D)
BD MEDICAL - DIABETES CARE
1329 west highway 6
holdrege NE 68949
MDR Report Key12334620
MDR Text Key267056782
Report Number1920898-2021-00903
Device Sequence Number1
Product Code FMF
UDI-Device Identifier00382908440035
UDI-Public00382908440035
Combination Product (y/n)N
PMA/PMN Number
K024112
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,other
Type of Report Initial,Followup
Report Date 08/18/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
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 Number0293915
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/02/2021
Initial Date Manufacturer Received 07/20/2021
Initial Date FDA Received08/17/2021
Supplement Dates Manufacturer Received08/18/2021
Supplement Dates FDA Received08/27/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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