MAUDE Adverse Event Report: B.BRAUN MEDICAL INC. DESIGN OPTIONS; NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)

Catalog Number 560603

Device Problem Defective Device (2588)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/13/2017

Event Type  malfunction  

Event Description

Recently, the anesthesia department experienced four inadequate spinals.Some patients needed to be converted to general during the procedure.We believe all the faulty spinals that day were from the same lot.As this lot number was found in both locations of occurrences: ob ors and main or.

• Brand Name: DESIGN OPTIONS
• Type of Device: NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)
• Manufacturer (Section D): B.BRAUN MEDICAL INC.; 901 marcon blvd.; allentown PA 18109
• MDR Report Key: 6413135
• MDR Text Key: 70219960
• Report Number: 6413135
• Device Sequence Number: 1
• Product Code: BSP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 04/30/2018
• Device Catalogue Number: 560603
• Device Lot Number: 0061527762
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/24/2017
• Event Location: Hospital
• Date Report to Manufacturer: 02/24/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/17/2017
• 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 Number: 1