MAUDE Adverse Event Report: BD BD WHITACRE SPINAL TRAY; ANESTHESIA CONDUCTION KIT

Model Number 406704

Device Problems Mechanical Problem (1384); Physical Resistance (2578); Positioning Problem (3009)

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

Event Date 12/21/2016

Event Type  malfunction  

Event Description

Anesthesia was placing epidural for a labor patient, physician felt resistance while using syringe.Upon inspection, noted a portion of a plunger inside the glass syringe.

• Brand Name: BD WHITACRE SPINAL TRAY
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): BD; 5859 farinon drive; suite 200; san antonio TX 78249
• MDR Report Key: 6240520
• MDR Text Key: 64476732
• Report Number: 6240520
• Device Sequence Number: 1
• Product Code: CAZ
• 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: 12/21/2016,12/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 01/01/2018
• Device Model Number: 406704
• Device Lot Number: B03K189D
• Other Device ID Number: B03K189D
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/21/2016
• Event Location: Hospital
• Date Report to Manufacturer: 12/21/2016
• 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
• Treatment: NO
• Patient Age: 38 YR