MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW EPIDURAL CATHETERIZATION KIT; ANESTHESIA CONDUCTION CATHETER

Model Number	IPN919609
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/25/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Reported event: the needle broke; it occurred in a manner that allowed for retrieval of both parts of the epidural needle.
Additional Manufacturer Narrative
Qn#(b)(4).The device investigation is pending and a follow-up report will be issued after the investigation is completed.Teleflex will continue to monitor and trend related events.
Additional Manufacturer Narrative
Qn (b)(4).The customer reported the epidural needle broke during use.The customer returned one epidural needle.The needle was returned with the cannula in two pieces.The returned sample was visually examined with and without magnification.Visual examination revealed the needle's cannula is bent near the hub connection.The separated cannula piece is also bent.Both cannula pieces appear to be bent at the point of separation.The needle bevel appears typical as not damage was observed.No other defects or anomalies were observed.The customer also provided a photo that appears to show an epidural needle broken into two pieces.A device history record review was performed on the epidural needle with no relevant findings.The reported complaint of the epidural needle breaking during use was confirmed based on the sample received.The needle's cannula was returned in two pieces.Visual examination revealed both cannula pieces were bent.Also, both cannula pieces appear to be bent at the point of separation.However, the needle bevel appears typical as no damage was observed.A device history record review was performed on the epidural needle with no relevant findings.It is unknown how the needle was handled prior to and during use.The investigation found no evidence to suggest a manufacturing related cause.Therefore, the potential cause of this complaint could not be determined.No further action is required at this time.
Event or Problem Description
Reported event: the needle broke; it occurred in a manner that allowed for retrieval of both parts of the epidural needle.

• Brand Name: ARROW EPIDURAL CATHETERIZATION KIT
• Common Device Name: ANESTHESIA CONDUCTION CATHETER
• 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 ; 9194332672
• MDR Report Key: 16233724
• Report Number: 1036844-2023-00006
• Device Sequence Number: 15166561
• Product Code: BSO
• UDI-Device Identifier: 10801902189117
• UDI-Public: 10801902189117
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K140110
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 12/28/2022

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: 09/30/2023
• Device Model Number: IPN919609
• Device Catalogue Number: AK-05502
• Device Lot Number: 37F22B0001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/28/2022
• Supplement Date Received by Manufacturer: 02/10/2023
• Initial Report FDA Received Date: 01/24/2023
• Supplement Report FDA Received Date: 02/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/18/2022
• 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: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NONE REPORTED; NONE REPORTED
• Patient Sex: Female