MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC SPINAL ANESTHESIA KIT; NEEDLE, CONDUCTION, ANESTHETI

Model Number	IPN045632
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "introducer needle bent with very little manipulation while in the patient.Anesthesia retracted the needle, bent it back to straighten, and it snapped".Additional information states that "no harm occurred.This needle bent in the patient but broke external to the patient".The issue was resolved by opening a new kit and using a new introducer and spinal needle.The procedure was completed successfully.
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
It was reported that "introducer needle bent with very little manipulation while in the patient.Anesthesia retracted the needle, bent it back to straighten, and it snapped".Additional information states that "no harm occurred.This needle bent in the patient but broke external to the patient".The issue was resolved by opening a new kit and using a new introducer and spinal needle.The procedure was completed successfully.
Additional Manufacturer Narrative
Qn#(b)(4).The actual device was not returned; however, the customer provided a photo for evaluation.The photo shows a needle with a broken cannula.The complaint was confirmed based on the photo.Without the device to evaluate, the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: SPINAL ANESTHESIA KIT
• Common Device Name: NEEDLE, CONDUCTION, ANESTHETI
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 312 commerce place; asheboro NC 27203
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 16769037
• Report Number: 1036844-2023-00033
• Device Sequence Number: 16953326
• Product Code: BSP
• UDI-Device Identifier: 50801902074190
• UDI-Public: 50801902074190
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K911260
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2023

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 Model Number: IPN045632
• Device Catalogue Number: ASA-25090-SB
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/06/2023
• Supplement Date Received by Manufacturer: 05/23/2023
• Initial Report FDA Received Date: 04/19/2023
• Supplement Report FDA Received Date: 05/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown