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

Model Number	SJ-05501
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/13/2021
Type of Reportable Event	Malfunction
Event or Problem 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
• Common Device Name: CATHETER, CONDUCTION, ANESTHETIC
• Manufacturer (Section D): TELEFLEX / ARROW INTERNATIONAL, INC. (SUBSIDIARY OF TELEFLEX, INCORPORATED)
• MDR Report Key: 12883029
• Report Number: MW5105616
• Device Sequence Number: 4265108
• Product Code: BSO
• UDI-Device Identifier: 50801902013694
• UDI-Public: (01)50801902013694
• Combination Product (Y/N): Y
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 22 YR
• Patient Sex: Female
• Patient Weight: 93 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White