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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 328325
Device Problem Failure to Deliver (2338)
Patient Problem Hypersensitivity/Allergic reaction (1907)
Event Date 03/22/2021
Event Type  malfunction  
Manufacturer Narrative
(b)(6).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 ultra-fine¿ ii insulin syringe plunger became "stuck" during use.The following information was provided by the initial reporter, translated from portuguese to english: "patient informs that felt pain to apply growth hormone.Felt the needle "grabbing" to skin, rough.The plunger is stuck, and needle is dull.Muscle became stiff like a lump.Reports that performs the applying local rotation and does not reuse the needles.".
 
Manufacturer Narrative
H6: investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.A review of the manufacturing records was performed, and no non-conformances were raised in association with this type of event for this lot.A review of the device history record was completed for batch# 9308326.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.H3 other text : see h10.
 
Event Description
It was reported that the bd ultra-fine¿ ii insulin syringe plunger became "stuck" during use.The following information was provided by the initial reporter, translated from portuguese to english: "patient informs that felt pain to apply growth hormone.Felt the needle "grabbing" to skin, rough.The plunger is stuck, and needle is dull.Muscle became stiff like a lump.Reports that performs the applying local rotation and does not reuse the needles.".
 
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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
MDR Report Key11690757
MDR Text Key246767027
Report Number1920898-2021-00425
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign,other
Type of Report Initial,Followup
Report Date 05/07/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/19/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Catalogue Number328325
Device Lot Number9308326
Was Device Available for Evaluation? No
Date Manufacturer Received05/07/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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