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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD ULTRA-FINE¿ II INSULIN SYRINGE; PISTON SYRINGE
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BD MEDICAL - DIABETES CARE BD ULTRA-FINE¿ II INSULIN SYRINGE; PISTON SYRINGE Back to Search Results
Catalog Number 326638
Device Problem Contamination of Device Ingredient or Reagent (2901)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/28/2023
Event Type  malfunction  
Manufacturer Narrative
H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.D.4 device expiration date: unknown.H.4.Device manufacture date: unknown.
 
Event Description
It was reported that 50 of the bd ultra-fine¿ ii insulin syringe experienced foreign matter, contaminated.The following information was provided by the initial reporter, translated from chinese to english: there was a drop of water in the syringe, and one drop came out at first.
 
Event Description
It was reported that 50 of the bd ultra-fine¿ ii insulin syringe experienced foreign matter, contaminated.The following information was provided by the initial reporter, translated from chinese to english: there was a drop of water in the syringe, and one drop came out at first.
 
Manufacturer Narrative
H6: investigation summary: customer returned (60) 0.3ml 30g 8mm syringes loose in a clear ziploc bag.There was a drop of water in the syringe, and one drop came out at first.Thirty return samples were tested by pushing the plunger and small clear droplet of material came out of the cannula from only one syringe.A small portion of this material was removed from the sample and prepared for ftir spectral analysis.The spectral analysis shows that this material is most likely silicone.Due to the batch being unknown, no dhr review can be completed.Embecta was able to confirm the foreign material as silicone.A definitive a definitive root-cause could not be determined.H3 other text : see h10.
 
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Brand Name
BD ULTRA-FINE¿ II 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 Key16754406
MDR Text Key313440153
Report Number1920898-2023-00232
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 07/13/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/17/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number326638
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/13/2023
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/13/2023
Was Device Evaluated by Manufacturer? Yes
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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