MAUDE Adverse Event Report: ARROW INTERNATIONAL, INC. (SUBSIDIARY OF TELEFLEX, INC.) SUREBLOCK SPROTTE SPINAL NEEDLE; SPINAL ANESTHESIA KIT

Model Number	ASA-25090-SB
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Event or Problem Description
Introducer needles in arrow spinal tray bend and snap off at hub.Fda safety report id# (b)(4).

• Brand Name: SUREBLOCK SPROTTE SPINAL NEEDLE
• Common Device Name: SPINAL ANESTHESIA KIT
• Manufacturer (Section D): ARROW INTERNATIONAL, INC. (SUBSIDIARY OF TELEFLEX, INC.)
• MDR Report Key: 8739513
• Report Number: MW5087642
• Device Sequence Number: 16476329
• Product Code: OFU
• UDI-Device Identifier: 50801902074190
• UDI-Public: (01)50801902074190
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 06/24/2019

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: 06/30/2020
• Device Model Number: ASA-25090-SB
• Device Catalogue Number: ASA-25090-SB
• Device Lot Number: 23F18L0024
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1