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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD BD LUER-LOK; SYRINGE, PISTON
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BD BD LUER-LOK; SYRINGE, PISTON Back to Search Results
Catalog Number 309657
Device Problems Fluid/Blood Leak (1250); Moisture Damage (1405)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/27/2017
Event Type  malfunction  
Event Description
Lpn drew up rocephin and immediately noted the syringe to have fluid behind the plunger prior to injection.Lpn then had an additional failure in the same lot number and was able to replicate the problem with up to 3 syringes.There was no patient contact with defective syringes.All other syringes by same lot number isolated.Interpretation by practice manager: it appears the plunger turns sideways just a little bit, allowing fluid to escape behind the plunger into the barrel of the syringe above the plunger.Manufacturer response for syringe, 3ml bd syringe-leur lock (per site reporter).A voice mail was left with bd customer service regarding product complaint.Defective product is to be sent back to manufacturer via ups 2nd day air.
 
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Brand Name
BD LUER-LOK
Type of Device
SYRINGE, PISTON
Manufacturer (Section D)
BD
1329 west highway
holdrege NE 68949
MDR Report Key7141827
MDR Text Key95620918
Report Number7141827
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 11/28/2017,12/07/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/22/2017
Is this a Product Problem Report? Yes
Device Operator Nurse
Device Expiration Date04/30/2022
Device Catalogue Number309657
Device Lot Number7122994
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/28/2017
Event Location Outpatient Treatment Facility
Date Report to Manufacturer11/28/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Treatment
NO OTHER THERAPIES
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