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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE; PISTON SYRINGE
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BD MEDICAL - DIABETES CARE BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE; PISTON SYRINGE Back to Search Results
Catalog Number 328431
Device Problems Complete Blockage (1094); Failure to Deliver (2338)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/14/2023
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each additional lot number is as follows: medical device lot #: 2094869, medical device expiration date: 30-apr-2027, device manufacture date: 04-apr-2022; medical device lot #: 1172426 , medical device expiration date: 31-jul-2026, device manufacture date: 21-jun-2021.
 
Event Description
It was reported that the bd insulin syringes with bd ultra-fine¿ needle plunger got stuck and unable to receive the insulin dose.The following information was provided by the initial reporter: that when trying to administer insulin the plunger gets stuck and she is unable to receive her insulin dose.
 
Event Description
It was reported that the bd insulin syringes with bd ultra-fine¿ needle plunger got stuck and unable to receive the insulin dose.The following information was provided by the initial reporter: that when trying to administer insulin the plunger gets stuck and she is unable to receive her insulin dose.
 
Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 08-may-2023.H6: investigation summary customer returned a total of (24) 0.3ml 30ga 12.7mm syringes.(4) in an open polybag from lot# 1172426, (10) in a closed polybag from lot# 1172426 and (10) in a closed polybag from lot# 2094869.It was reported by the customer that when trying to administer insulin, the plunger gets stuck and they are unable to receive the insulin dose.All the syringes were visually verified using magnification and found no damages/issues.Performed a functional test on all syringes using water and was able to draw water into the syringe without any issues.All syringes were performed as intended without issues.Therefore, embecta was not able to confirm the customer indicated issue.A review of the device history record was completed for batch # 2094869 all inspections were performed per the applicable operations qc specifications.There were zero (0) notifications noted that did not pertain to the complaint.Based on the sample received, embecta was not able to confirm the reported issue.The root cause could not be determined because the issue could not be confirmed.
 
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Brand Name
BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE
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 Key16643798
MDR Text Key312501044
Report Number1920898-2023-00177
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K024112
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Consumer
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 07/20/2023
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 Lay User/Patient
Device Catalogue Number328431
Device Lot NumberSEE H.10
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/14/2023
Initial Date FDA Received03/30/2023
Supplement Dates Manufacturer Received07/20/2023
Supplement Dates FDA Received08/08/2023
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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