Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD¿ VETERINARY INSULIN SYRINGE
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BD MEDICAL - DIABETES CARE BD¿ VETERINARY INSULIN SYRINGE Back to Search Results
Catalog Number 323000
Device Problem Retraction Problem (1536)
Patient Problems Hemorrhage/Bleeding (1888); Needle Stick/Puncture (2462)
Event Date 10/10/2018
Event Type  Injury  
Manufacturer Narrative
Medical device expiration date: n/a.Device manufacture date: unknown.Investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.Complaints received for this device and reported condition will continue to be tracked and trended.If samples are received in the future the complaint will be reopened for further investigation.Unable to perform dhr due to unknown lot number investigation conclusion: bd was not able to duplicate or confirm the customer¿s indicated failure as no samples or photos were returned.Root cause description: root cause cannot be determined at this time as the issue is unconfirmed as no samples or photos were returned.Rationale: based on the investigation, no additional investigation and no capa is required at this time.
 
Event Description
It was reported that after use, the user was attempting to re-cap bd¿ veterinary insulin syringes.The needle poked through the shield causing a needle stick and minor bleeding to the user.There was no report of medical intervention.
 
Manufacturer Narrative
Investigation summary: customer returned (1) loose 1/2cc bd u40 syringe.Customer states that when her husband went to re shield the syringe after injection that the needle poked the pet owner.The returned syringe was examined and exhibited the cannula through the shield, exposing the cannula, which could cause a needle stick.Based on the samples / photo(s) received the investigation concluded: confirmed: bd was able to duplicate or confirm the customer¿s indicated failure (needle stick and cannula through shield).Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.Based on the above, no capa is required at this time.Possible root causes for needle through shield include: manufacturing process: needle was bent during the shielding process and was not detected at the point inspect machine, where an electrical current is passed over the shield and ejects parts where an arc is detected.Additionally, needle through shield would have had to pass through undetected by the camera system utilized on the production line.Both systems are challenged at regular intervals during production.
 
Event Description
It was reported that after use, the user was attempting to re-cap bd¿ veterinary insulin syringes.The needle poked through the shield causing a needle stick and minor bleeding to the user.There was no report of medical intervention.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
BD¿ VETERINARY INSULIN SYRINGE
Type of Device
INSULIN SYRINGE
Manufacturer (Section D)
BD MEDICAL - DIABETES CARE
1329 west highway 6
holdrege NE 68949
MDR Report Key8020249
MDR Text Key125512352
Report Number1920898-2018-00811
Device Sequence Number1
Product Code FMF
UDI-Device Identifier00382903230006
UDI-Public00382903230006
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Type of Report Initial,Followup
Report Date 11/29/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Catalogue Number323000
Device Lot NumberUNKNOWN
Initial Date Manufacturer Received 10/10/2018
Initial Date FDA Received10/30/2018
Supplement Dates Manufacturer Received10/10/2018
Supplement Dates FDA Received11/29/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
-
-