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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

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BD MEDICAL - DIABETES CARE VET SYRINGE 0.3ML X 29G X 12.7MM 10 BAG Back to Search Results
Model Number 323000
Device Problem Leak/Splash (1354)
Patient Problem Needle Stick/Puncture (2462)
Event Date 08/09/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Investigation summary: level b investigation. Complaint evaluation / complaint history check for the event(s) that occurred. Severity: s_2__; occurrence: a complaint history check was performed and this is the 1st related complaint for does not detach as intended, needle hub separates and needle stick (clean) on lot # 9266921. A review of risk management 150rmn-0001-16 revision 13 indicates that the potential risk of this specific reported incident (syringe, shield does not detach as intended, needle hub separates, needle stick) was captured and addressed investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed. If samples are received in the future the complaint will be reopened for further investigation. A review of the device history record was completed for batch # 9266921 all inspections were performed per the applicable operations qc specifications. There was one (1) notification [200879125] noted that did not pertain to the complaint. 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 during use the vet syringe 0. 3ml x 29g x 12. 7mm 10 bag experienced shield/cap does not attach/detach and needlestick injury - self. The following information was provided by the initial reporter: the customer stated that with four syringes it was hard to remove shields and the needle hub assembly separated when removed. Also reported, on one of these syringes she pulled hard and needle stuck her finger. No medical attention sought.
 
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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 Key10434288
MDR Text Key205156653
Report Number1920898-2020-01104
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
Type of Report Initial
Report Date 08/13/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/20/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number323000
Device Catalogue Number323000
Device Lot Number9266921
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
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
Date Device Manufactured09/23/2019
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: 08/20/2020 Patient Sequence Number: 1
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