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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: B. BRAUN MEDICAL, INC. B BRAUN LUER LOCK-OF-RESISTANCE SYRINGE ANESTHESIA CONDUCTION KIT

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B. BRAUN MEDICAL, INC. B BRAUN LUER LOCK-OF-RESISTANCE SYRINGE ANESTHESIA CONDUCTION KIT Back to Search Results
Model Number REF# 332152
Device Problem Loose or Intermittent Connection (1371)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/08/2020
Event Type  malfunction  
Event Description
Loss-resistant syringe does not luer lock securely onto spinal access device during procedure. Several syringes from this lot number, all would not lock securely. Same device from different lot number worked properly; 47 syringes from this lot removed from service. (46 syringes being sent to b braun and hosp risk mgr keeping one syringe). Packaging info: (b)(4).
 
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Brand NameB BRAUN LUER LOCK-OF-RESISTANCE SYRINGE
Type of DeviceANESTHESIA CONDUCTION KIT
Manufacturer (Section D)
B. BRAUN MEDICAL, INC.
bethlehem PA 18018
MDR Report Key10055625
MDR Text Key191115724
Report NumberMW5094484
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Type of Report Initial
Report Date 05/11/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/13/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberREF# 332152
Device Lot Number0061701741
Was Device Available for Evaluation? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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