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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE UNSPECIFIED BD SYRINGE; PISTON SYRINGE
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BD MEDICAL - DIABETES CARE UNSPECIFIED BD SYRINGE; PISTON SYRINGE Back to Search Results
Catalog Number UNKNOWN
Device Problem Defective Device (2588)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/20/2021
Event Type  malfunction  
Manufacturer Narrative
Medical device expiration date : unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Medical device manufacture date : unknown.
 
Event Description
It was reported that 2 unspecified bd¿ syringe had product damage issues.The following information was provided by the initial reporter : the consumer reported that the plunger snapped in half when taking the injection and needle shields are difficult to remove.Date of event : (b)(6) 2021.Samples : yes.
 
Manufacturer Narrative
The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 8/10/2021.H.6.Investigation: customer returned (1) loose 0.5ml bd insulin syringe.The customer reported that the plunger snapped in half when taking injection and needle shields are difficult to remove.The returned syringe was examined, and it was observed that the plunger rod was fractured approximately 1¿ from the thumbpress; the plunger rod assembly was fully depressed within the barrel.The returned syringe was examined, then tested to determine the shield removal force and measured within specification at 3.19 lbs (specs: shield removal force for 0.5 ml syringe after sterilization is 0.85 to 5.95lbs).No defects were observed.Due to the batch being unknown, no dhr review can be completed.Root cause for this defect cannot be determined.
 
Event Description
It was reported that 2 unspecified bd¿ syringe had product damage issues.The following information was provided by the initial reporter : the consumer reported that the plunger snapped in half when taking the injection and needle shields are difficult to remove.Date of event : (b)(6) 2021.Samples : yes.
 
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Brand Name
UNSPECIFIED BD SYRINGE
Type of Device
PISTON SYRINGE
Manufacturer (Section D)
BD MEDICAL - DIABETES CARE
1329 west highway 6
holdrege NE 68949
MDR Report Key12334592
MDR Text Key267071191
Report Number1920898-2021-00902
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
PMA/PMN Number
K024112
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Type of Report Initial,Followup
Report Date 08/27/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/17/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/10/2021
Date Manufacturer Received08/23/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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