MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. PERIFIX ; SINGLE DOSE EPIDURAL ANESTHESIA

Catalog Number 04046964186202

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Code Available (3191)

Event Date 12/01/2017

Event Type  malfunction  

Event Description

Md noticed residue on skin of pt after using epidural needle from epidural tray.This prompted md to wipe needle taken out of tray with 4x4 before using.Rescue did not come off needle onto 4x4.Needle was replaced and not used.

• Brand Name: PERIFIX
• Type of Device: SINGLE DOSE EPIDURAL ANESTHESIA
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; bethlehem PA 18018
• MDR Report Key: 7100821
• MDR Text Key: 94408330
• Report Number: MW5073840
• 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: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2019
• Device Catalogue Number: 04046964186202
• Device Lot Number: 0061581498
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• 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
• Patient Age: 66 YR
• Patient Weight: 75