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

Model Number	IPN919630
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).The device has not been returned for investigation.
Event or Problem Description
Arrow epidural cath that had a random hole in it (identified after patient already had catheter in her back), so epidural catheter had to be replaced.There was no patient harm/injury/consequence.The patient is reported to be fine.There was a delay/interruption in treatment.It is unknown if the patient was exposed to infectious disease.
Event or Problem Description
Arrow epidural cath that had a random hole in it (identified after patient already had catheter in her back), so epidural catheter had to be replaced.There was no patient harm/injury/consequence.The patient is reported to be fine.There was a delay/interruption in treatment.It is unknown if the patient was exposed to infectious disease.
Additional Manufacturer Narrative
(b)(4).A device history record review was performed on the epidural catheter with no relevant findings.The customer reported the catheter had a hole.The customer returned one snaplock assembly, one epidural catheter, and lidstock.The returned components were received connected together.The returned components were visually examined with and without magnification.Visual examination of the returned snaplock assembly revealed the snaplock appears typical with no observed defects or anomalies.Visual examination of the returned catheter revealed that the catheter appears used as biological material can be seen on the inner coils.Microscopic examination of the catheter revealed the catheter is damaged at approximately 11.5cm (ruler: ref-003101) from the distal end.The extrusion appears to have a cut/hole.No other damage was observed.Functional inspection was performed on the returned sample.A functional leak test was performed per amrq-000017 section 7.5 rev.10, using the returned catheter and snaplock assembly with the lab leak tester (ref-002902).The proximal end of the catheter was inserted into the snaplock assembly until it bottomed out and the components were locked.The catheter was confirmed to be secured by tugging gently.The snaplock assembly was then connected to the lab leak tester and the pressure was increased to 10 psi to establish flow.The distal end of the catheter was then capped off and the pressure was increased to 25 psi for 30 seconds.A leak was detected coming from the same location where the catheter has a hole at 11.5cm from the distal end, which was revealed during the visual inspection.No other leaks were detected.A corrective action is not required at this time as the investigation shows no evidence to suggest a manufacturing related cause.All epidural catheters are tested for leaks at the time of manufacturing.The hole in the catheter was detected during use.Therefore, based on the condition of the sample received and the time of discovery indicate unintentional user error caused or contributed to this event.The reported complaint of the catheter having a hole was confirmed based on evaluation of the sample received.During the functional inspection, the returned epidural catheter was confirmed to leak from where the catheter was damaged at approximately 11.5cm from the distal end.All epidural catheters are 100% tested for leaks at the time of manufacturing.A device history record review was performed on the epidural catheter with no evidence to suggest a manufacturing related issue.The hole in the catheter was detected during use.Therefore, based on the time of discovery and the condition of the sample received, unintentional user error caused or contributed to this event.No further action is required at this time.

• Brand Name: 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: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 14982457
• Report Number: 1036844-2022-00051
• Device Sequence Number: 17417835
• Product Code: BSO
• UDI-Device Identifier: 10801902189315
• UDI-Public: 10801902189315
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2022

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: 02/29/2024
• Device Model Number: IPN919630
• Device Catalogue Number: SJ-05501
• Device Lot Number: 13F22D0737
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2022
• Supplement Date Received by Manufacturer: 08/18/2022
• Initial Report FDA Received Date: 07/11/2022
• Supplement Report FDA Received Date: 08/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/18/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown