MAUDE Adverse Event Report: TELEFLEX / ARROW INTERNATIONAL, INC. (SUBSIDIARY OF TELEFLEX, INCORPORATED) ARROW EPIDURAL INSERTION KIT; CATHETER, CONDUCTION, ANESTHETIC

Model Number SJ-05501

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

Patient Problem Insufficient Information (4580)

Event Date 10/13/2021

Event Type  malfunction  

Event Description

While the anesthesiologist was preparing the epidural tray contents for insertion, he noticed the contents in the lidocaine vial did not contain any liquid only crystals.The anesthesiologist discarded the entire contents of the tray and obtained a new one.Fda safety report id # (b)(4).

• Brand Name: ARROW EPIDURAL INSERTION KIT
• Type of Device: CATHETER, CONDUCTION, ANESTHETIC
• Manufacturer (Section D): TELEFLEX / ARROW INTERNATIONAL, INC. (SUBSIDIARY OF TELEFLEX, INCORPORATED)
• MDR Report Key: 12883029
• MDR Text Key: 281417035
• Report Number: MW5105616
• Device Sequence Number: 1
• Product Code: BSO
• UDI-Device Identifier: 50801902013694
• UDI-Public: (01)50801902013694
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/23/2021

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: Health Professional
• Device Expiration Date: 07/31/2022
• Device Model Number: SJ-05501
• Device Catalogue Number: SJ-05501
• Device Lot Number: 23F21E0090
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 22 YR
• Patient Sex: Female
• Patient Weight: 93 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White