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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD ULTRA-FINE¿ II SHORT NEEDLE INSULIN SYRINGE; PISTON SYRINGE
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BD MEDICAL - DIABETES CARE BD ULTRA-FINE¿ II SHORT NEEDLE INSULIN SYRINGE; PISTON SYRINGE Back to Search Results
Catalog Number 326725
Device Problem Contamination (1120)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/05/2023
Event Type  malfunction  
Event Description
It was reported while using bd ultra-fine¿ ii short needle insulin syringe foreign matter was found.There was no report of patient impact.The following information was provided by the initial reporter: customer report that there is a problem with the product, there is moisture inside the package and release steam.Found amount 3 boxes.
 
Manufacturer Narrative
H.3.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 while using bd ultra-fine¿ ii short needle insulin syringe foreign matter was found.There was no report of patient impact.The following information was provided by the initial reporter: customer report that there is a problem with the product, there is moisture inside the package and release steam.Found amount 3 boxes.
 
Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: (b)(6) 2023.H6: investigation summary customer returned 3 shelf cartons full of unopen blister packs and a single blister pack open.Customer report that there is a problem with the product, there is moisture inside the package and release steam.The returned product was visually inspected and scratches on the blister pack film were observed on all the syringes.On the open blister the marks on the film could not be wiped from the inner side, which confirmed that was not steam but marking on the film.A review of the device history record was completed for batch# (b)(4).All inspections and challenges were performed per the applicable operations qc specifications.Based on the sample received, embecta was able to confirm scratches on the blister pack film.No definitive root cause can be determined.H3 other text : see h10.
 
Manufacturer Narrative
The following fields were updated due to additional information: investigation summary customer returned 3 shelf cartons full of unopen blister packs and a single blister pack open.Also pictures of the product were provided from the customer.Customer report that there is a problem with the product, there is moisture inside the package and release steam.Initially the photos were examined and no issues were observed.The returned product was visually inspected and scratches on the blister pack film were observed on all the syringes.On the open blister the marks on the film could not be wiped from the inner side, which confirmed that was not steam but marking on the film.A review of the device history record was completed for batch# 2010670.All inspections and challenges were performed per the applicable operations qc specifications.Based on the sample received, embecta was able to confirm scratches on the blister pack film.No definitive root cause can be determined.
 
Event Description
It was reported while using bd ultra-fine¿ ii short needle insulin syringe foreign matter was found.There was no report of patient impact.The following information was provided by the initial reporter: customer report that there is a problem with the product, there is moisture inside the package and release steam.Found amount 3 boxes.
 
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Brand Name
BD ULTRA-FINE¿ II SHORT NEEDLE 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
phillip emmert
9450 south state street
sandy, UT 84070
8448235433
MDR Report Key16825576
MDR Text Key314115316
Report Number1920898-2023-00261
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeTH
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,Followup
Report Date 09/14/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/27/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number326725
Device Lot Number2010670
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received09/14/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/10/2022
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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