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

Catalog Number EJ-05400-NRO

Device Problem No Flow (2991)

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

Event Date 07/27/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has not been returned for investigation.

Event Description

The medical agent did not flow through the catheter while in use on a patient.Therefore, the catheter was removed and replaced with a new kit.

Manufacturer Narrative

(b)(4).A device history record review was performed on the epidural catheter with no relevant findings.The customer reported the medical agent would not flow through the catheter.The customer returned one snaplock assembly nrfit, one epidural catheter, and lidstock.The returned components were received connected.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 the catheter appears used.Biological material can be seen between the inner coils especially at the distal.No other defects or anomalies were observed.A functional flow test was performed on the returned sample.The returned epidural catheter was inserted from the proximal end into the returned snaplock assembly until it bottomed out and the snaplock assembly was closed.The components were confirmed to be secured by tugging gently.The snaplock assembly was connected to the lab leak tester and the pressure was increased to 10 psi to establish flow.No flow could be established out of the distal tip of the catheter.The test was repeated using the returned snaplock assembly and lab inventory epidural catheter.Flow could be established to the distal tip of the catheter, indicating that there are no flow issues with the returned snaplock assembly.An attempt was made to thread a lab inventory wire through the epidural catheter from the proximal end.The wire threaded approximately 49.7cm (ruler: ref-003101) from the proximal end of the returned catheter until an occlusion was found.An attempt was made to thread a lab inventory wire through the epidural catheter from the distal end.The wire threaded approximately 26mm from the distal end of the returned catheter until an occlusion was found.The wire appears to stop in the catheter from both directions at two different locations.In summary, the reported complaint of the medical agent not flowing through the catheter was confirmed during functional inspection of the returned sample.The returned epidural catheter was found to be completely occluded.An attempt to thread a lab wire through the catheter revealed an occlusion at two different locations.A device history record review was performed on the epidural catheter with no evidence to suggest a manufacturing related cause.Based upon the information provided and the condition of the sample received, the potential cause of this complaint could not be determined.The returned sample will be returned to the manufacturing site for further evaluation.

Event Description

The medical agent did not flow through the catheter while in use on a patient.Therefore, the catheter was removed and replaced with a new kit.

Manufacturer Narrative

(b)(4).The customer reported the medical agent would not flow through the catheter.The customer returned one snaplock assembly nrfit, one epidural catheter connected together and lidstock.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 the catheter appears used as biological material can be seen between the inner coils especially at the distal end.No other defects or anomalies were observed.Dimensional inspection was not required as a part of this complaint investigation.The returned epidural catheter was inserted from the proximal end into the returned snaplock assembly until it bottomed out and the snaplock assembly was closed.The components were confirmed to be secured by tugging gently.A functional flow test was performed on the returned sample and no flow could be established out of the distal tip of the catheter.The test was repeated using the returned snaplock assembly and lab inventory epidural catheter.Flow could be established to the distal tip of the catheter, indicating that there are no flow issues with the returned snaplock assembly.An attempt was made to thread a laboratory inventory wire through the epidural catheter from the proximal end.The returned sample was returned to the manufacturing site for further evaluation.The manufacturing site's evaluation concluded; the issue was not manufacturing related.The manufacturing site stated "received catheter would not pass the inspection mechanisms of the process.The damage must have been caused by mechanical handling".A device history record review was performed on the epidural catheter with no relevant findings.A corrective action is not required at this time as the root cause for this complaint investigation could not be determined based upon the information provided and the condition of the sample received.Therefore, based upon the information provided and the condition of the sample received, the potential cause of this complaint could not be determined.No further action is required at this time.

Event Description

The medical agent did not flow through the catheter while in use on a patient.Therefore, the catheter was removed and replaced with a new kit.

• Brand Name: EPIDURAL CATHETERIZATION SET NRFIT
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL CR, A.S.; jamska 2359/47; zdar nad sazavou 591 0 1; EZ 591 01
• Manufacturer Contact: effie jefferson ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194332672
• MDR Report Key: 15163513
• MDR Text Key: 304893296
• Report Number: 3006425876-2022-00710
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup,Followup
• Report Date: 07/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2023
• Device Catalogue Number: EJ-05400-NRO
• Device Lot Number: 71F21K0666
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/14/2021
• 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