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

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).

• Brand Name: B BRAUN LUER LOCK-OF-RESISTANCE SYRINGE
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): B. BRAUN MEDICAL, INC.; bethlehem PA 18018
• MDR Report Key: 10055625
• MDR Text Key: 191115724
• Report Number: MW5094484
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 05/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: REF# 332152
• Device Lot Number: 0061701741
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/13/2020
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1