MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. (SUBSIDIARY OF TELEFLEX, INC.) CONTINUOUS EPIDURAL NEEDLE; ANESTHESIA CONDUCTION KIT

Model Number REF AN-02017

Device Problem Break (1069)

Patient Problem No Code Available (3191)

Event Date 12/08/2018

Event Type  Injury  

Event Description

Lot: 23f18a0585 ref: an-02017.Labor epidural analgesia requested.Breakage of the epidural needle noted approximately 7cm into the procedure.Patient then taken to the operating room for retrieval of the remainder of the epidural needle which was retained in the patient's back.Successful retrieval.The product is being returned to the manufacturer on 12/13/2018.

• Brand Name: CONTINUOUS EPIDURAL NEEDLE
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): ARROW INTERNATIONAL INC. (SUBSIDIARY OF TELEFLEX, INC.); reading PA 19605
• MDR Report Key: 8160551
• MDR Text Key: 130464430
• Report Number: MW5082089
• 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
• Type of Report: Initial
• Report Date: 12/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2020
• Device Model Number: REF AN-02017
• Device Lot Number: 23F18A0585
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention