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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD INSULIN SYRINGES WITH THE BD ULTRA FINE¿NEEDLE; ANTI-STICK SAFETY SYRINGE
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BD MEDICAL - DIABETES CARE BD INSULIN SYRINGES WITH THE BD ULTRA FINE¿NEEDLE; ANTI-STICK SAFETY SYRINGE Back to Search Results
Catalog Number 305937
Device Problems Loose or Intermittent Connection (1371); Defective Component (2292)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/18/2022
Event Type  malfunction  
Event Description
It was reported that 1 bd insulin syringe with the bd ultra fine¿needle had damaged package and sterility issues.The following information was provided by the initial reporter : it was reported that the plunger caps seem less secure.
 
Manufacturer Narrative
Date of event: unknown.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.
 
Manufacturer Narrative
H6: investigation summary : no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.Due to the batch being unknown, no dhr review can be completed.
 
Event Description
It was reported that 1 bd insulin syringe with the bd ultra fine¿needle had damaged package and sterility issues.The following information was provided by the initial reporter : it was reported that the plunger caps seem less secure.
 
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Brand Name
BD INSULIN SYRINGES WITH THE BD ULTRA FINE¿NEEDLE
Type of Device
ANTI-STICK SAFETY 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
8015296192
MDR Report Key13667752
MDR Text Key287010972
Report Number1920898-2022-00142
Device Sequence Number1
Product Code MEG
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K992734
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Distributor
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 03/07/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number305937
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/18/2022
Initial Date FDA Received03/04/2022
Supplement Dates Manufacturer Received03/07/2022
Supplement Dates FDA Received03/22/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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