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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD ULTRA-FINE¿ 1/2ML INSULIN SYRINGE; PISTON SYRINGE
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BD MEDICAL - DIABETES CARE BD ULTRA-FINE¿ 1/2ML INSULIN SYRINGE; PISTON SYRINGE Back to Search Results
Catalog Number 326666
Device Problem Unsealed Device Packaging (1444)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/18/2023
Event Type  malfunction  
Event Description
It was reported that prior to use with bd ultra-fine¿ 1/2ml insulin syringe one unit was discovered to not be in the unit packaging, thus affecting sterility.The following information was provided by the initial reporter, translated from japanese to english: one polybag of product (32666) was not packaged.
 
Manufacturer Narrative
H.3.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 prior to use with bd ultra-fine¿ 1/2ml insulin syringe one unit was discovered to not be in the unit packaging, thus affecting sterility.The following information was provided by the initial reporter, translated from japanese to english: one polybag of product (32666) was not packaged.
 
Manufacturer Narrative
H6: investigation summary no samples were returned therefore the investigation was performed based on the photos provided.The customer returned three photos of the 0.5ml, 29-gauge bd syringe polybag.The customer reported torn polybag.The photos were examined and exhibited an open polybag across the top of the pouch.A review of the device history record was completed for batch# 2171563.All inspections and challenges were performed per the applicable operations qc specifications.Based on the photos received, embecta was able to confirm the customer¿s indicated failure (polybag damaged/torn).There were no quality notifications or dispatches that pertained to the complaint; therefore, no root cause can be determined.
 
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Brand Name
BD ULTRA-FINE¿ 1/2ML INSULIN SYRINGE
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
jennifer suh
9450 south state street
sandy, UT 84070
8448235433
MDR Report Key17456060
MDR Text Key320785770
Report Number1920898-2023-00520
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 09/14/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/03/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number326666
Device Lot Number2220146
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received09/14/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/08/2022
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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