MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC SPINAL ANES/EPIDURAL CATH KIT; ANESTHESIA CONDUCTION CATHETER

Model Number	IPN924969
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Reported issue: it was reported that the end of the tuohy has folded up on itself and the residents or attendings have been unable to pass the spinal needle or catheter through.Upon further questioning the doctor stated that she was not sure that anything broke/chipped off in the patient and that the resident that was placing the epidural claimed thought it chipped but i did not see anything at the end of the needle.The tip may have folded over itself.The bevel of needles appears flimsy , and i think they fold over themselves and occlude.She opened a second kit and placed a new epidural.The patient's current condition is unknown.
Additional Manufacturer Narrative
Qn# (b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
Additional Manufacturer Narrative
(b)(4).A device history record review could not be performed as no lot number was provided by the customer.A review of sales history data was performed to obtain a lot number.However, there was no record of purchase of this product by this customer.A corrective action is not required at this time as a potential root cause could not be determined based upon the information provided and without a sample.Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review could not be performed as no lot number was provided by the customer.Therefore, the potential cause of this complaint could not be determined based upon the information provided and without the sample.No further action is required at this time.
Event or Problem Description
Reported issue: it was reported that the end of the tuohy has folded up on itself and the residents or attendings have been unable to pass the spinal needle or catheter through.Upon further questioning the doctor stated that she was not sure that anything broke/chipped off in the patient and that the resident that was placing the epidural claimed thought it chipped but i did not see anything at the end of the needle.The tip may have folded over itself.The bevel of needles appears flimsy , and i think they fold over themselves and occlude.She opened a second kit and placed a new epidural.The patient's current condition is unknown.

• Brand Name: SPINAL ANES/EPIDURAL CATH 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: effie jefferson ; 3015 carrington mill blvd; morrisville 27560 ; 9194332672
• MDR Report Key: 15834300
• Report Number: 1036844-2022-00069
• Device Sequence Number: 20190376
• Product Code: BSO
• UDI-Device Identifier: 10801902209556
• UDI-Public: 10801902209556
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/17/2022

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 Model Number: IPN924969
• Device Catalogue Number: AK-05560
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2022
• Supplement Date Received by Manufacturer: 01/04/2023
• Initial Report FDA Received Date: 11/21/2022
• Supplement Report FDA Received Date: 01/10/2023
• 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: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NONE REPORTED; NONE REPORTED
• Patient Sex: Female