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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD VEO¿ INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE; PISTON SYRINGE
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BD MEDICAL - DIABETES CARE BD VEO¿ INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE; PISTON SYRINGE Back to Search Results
Catalog Number 324910
Device Problems Product Quality Problem (1506); Material Separation (1562)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/12/2023
Event Type  malfunction  
Event Description
It was reported that 300 of the bd veo¿ insulin syringes with bd ultra-fine¿ needle experienced excessive adhesive causing the plunger to separate.The following information was provided by the initial reporter: excessive silicon lubricant, separation plunger and thumb press customer stated that "the silicon oil is too much from the needle and when removing the cap, the plunger rod comes out together.
 
Manufacturer Narrative
Multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each additional lot number is as follows: d.4.Medical device lot #: 1242719.D.4.Medical device expiration date: 30-sep-2026.H.4.Device manufacture date: 30-aug-2021.D.4.Medical device lot #: 2010734.D.4.Medical device expiration date: 31-jan-2027.H.4.Device manufacture date: 10-jan-2022.H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
 
Manufacturer Narrative
The following fields were updated due to additional information: d9: device available for eval yes, d9: returned to manufacturer on: 28-jul-2023.H.6.Investigation summary: samples were received and an investigation was performed.This is the 10th complaint for the reported lot number 1242719 and the 1st complaint for the reported lot number 2010734.A review of the manufacturing records was performed and no non-conformances were raised in association with this type of event for this lot.Embecta was able to duplicate or confirm the indicated issue as silicone and based on trend analysis no further action is required at this time for lot 1242719 and not able to duplicate or confirm the indicated issue and based on trend analysis no further action is required at this time for lot 2010734.Complaints received for this device and reported condition will continue to be tracked and trended.Based on the above, no additional investigation and corrective/preventative action (capa) or situational analysis (sa) is required.
 
Event Description
It was reported that 300 of the bd veo¿ insulin syringes with bd ultra-fine¿ needle experienced excessive adhesive causing the plunger to separate.The following information was provided by the initial reporter: excessive silicon lubricant, separation plunger and thumb press customer stated that "the silicon oil is too much from the needle and when removing the cap, the plunger rod comes out together.
 
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Brand Name
BD VEO¿ 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
jennifer suh
5859 farinon drive
san antonio, TX 78249
8448235433
MDR Report Key17447002
MDR Text Key320297174
Report Number1920898-2023-00506
Device Sequence Number1
Product Code FMF
UDI-Device Identifier00382903249107
UDI-Public(01)00382903249107
Combination Product (y/n)N
Reporter Country CodeKS
PMA/PMN Number
K212499
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Consumer
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 11/09/2023
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 Number324910
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 Not provided
Initial Date FDA Received08/02/2023
Supplement Dates Manufacturer Received11/02/2023
Supplement Dates FDA Received11/14/2023
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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