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

Model Number IPN924969

Device Problem Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/28/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.

Event Description

Reported issue: people cannot get the spinal needle through the end of the t or pass the catheter.It bends upon contact with bone.There was no reported patient injury or consequence.

Event Description

Reported issue: people cannot get the spinal needle through the end of the t or pass the catheter.It bends upon contact with bone.There was no reported patient injury or consequence.

Manufacturer Narrative

(b)(4).Visual inspection could not be performed as no sample was returned for analysis.The customer did provide a photograph that appears to show a needle with a bent tip.A dimensional inspection could not be performed as no sample was returned for analysis.A functional inspection or additional 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.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.Additional document review was not required as a part of this complaint investigation.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.The customer did provide a photograph that appears to show a needle with a bent tip.However, the potential cause of this complaint could not be determined based upon the information provided and without a sample.No further action is required at this time.

• Brand Name: SPINAL ANES/EPIDURAL CATH KIT
• Type of Device: 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: 16017990
• MDR Text Key: 306355346
• Report Number: 1036844-2022-00072
• Device Sequence Number: 1
• Product Code: BSO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140110
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/28/2022

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
• Device Operator: 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
• Initial Date Manufacturer Received: 11/28/2022
• Initial Date FDA Received: 12/20/2022
• Supplement Dates Manufacturer Received: 01/12/2023
• Supplement Dates FDA Received: 01/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Treatment: NONE REPORTED; NONE REPORTED
• Patient Sex: Female