• 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 VET SYRINGE 0.3ML X 29G X 12.7MM 10 BAG

  • 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 VET SYRINGE 0.3ML X 29G X 12.7MM 10 BAG Back to Search Results
Model Number 323000
Device Problems Material Puncture/Hole (1504); Material Protrusion/Extrusion (2979)
Patient Problem Needle Stick/Puncture (2462)
Event Date 08/10/2020
Event Type  Injury  
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used for this field. Medical device expiration date: unknown. Device manufacture date: unknown. (b)(4). Investigation summary: level b investigation - complaint evaluation / complaint history check for the event(s) that occurred. Severity: s_3__; occurrence: unable to perform complaint lot history check for needle through shield and needle stick (dirty) due to unknown lot number. A review of risk management 150rmn-0001-16 revision 13 indicates that the potential risk of this specific reported incident (syringe, needle through shield, needle stick (dirty) was captured and addressed. Investigation summary: no samples were returned therefore the complaint could not be confirmed. If samples are received in the future the complaint will be reopened for further investigation. Unable to perform a dhr review for needle through shield and needle stick (dirty) due to unknown lot number. Investigation conclusion: as no samples and/or photo(s) were received the investigation concluded: unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure as no samples or photos were returned. 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. 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 vet syringe 0. 3ml x 29g x 12. 7mm 10 bag needle went through the shield and caused a needle stick. This was discovered during use. The following information was provided by the initial reporter: material no. 323000 batch no. Unknown. It was reported that when re-capping syringe, needle went through shield and caused needle stick. No medical attention received. Consumer reported in her prior box used for her cat had a syringe when recapped the shield to the needle, after injecting her cat, the needle went thru the shield and stuck her finger. No medical attention received. Claims finger healed fine without issues. Advised this pet owner not to reshield the syringes, just place them in the sharps container.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameVET SYRINGE 0.3ML X 29G X 12.7MM 10 BAG
Type of DeviceSYRINGE
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
brett wilko
9450 south state street
sandy, UT 84070
8015652341
MDR Report Key10418561
MDR Text Key203363561
Report Number1920898-2020-01082
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 08/14/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/18/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number323000
Device Catalogue Number323000
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/10/2020
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 Treatment Data
Date Received: 08/18/2020 Patient Sequence Number: 1
-
-