MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC EPIDURAL CATHETERIZATION KIT NRFIT

Catalog Number TU-05500-NRO

Device Problem No Flow (2991)

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

Event Date 02/14/2022

Event Type  malfunction  

Event Description

The user was unable to inject the medical agent through the catheter after insertion.Therefore, the catheter was replaced with a new one.Additional information: flushing test was performed on the catheter before insertion and after removal from the patient, but no problem was found then.

Manufacturer Narrative

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

Manufacturer Narrative

Qn# (b)(4).A device history record review was performed on the epidural catheter with no relevant findings.The customer reported the medical agent could not be injected through the catheter.The customer returned one flat filter nrfit, one snaplock assembly nrfit, and an epidural catheter.The returned snaplock assembly and catheter were received connected together.The returned components were visually examined with and without magnification.Visual examination of the returned filter and snaplock assembly revealed both components appear 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.No other defects or anomalies were observed.A functional flow test was performed on the returned sample per amrq-000017 section 7.8; rev.10.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 (ref-(b)(4) 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 46.6cm (ruler: 10171599) 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 43.8cm from the distal end of the returned catheter until an occlusion was found.Microscopic examination where the catheter was blocked indicated biological material is present between the catheter's inner coils.The extrusion of the returned catheter was cut at approximately 46cm from the proximal end to determined what was causing the occlusion.A clear crystalized looking material less than 1cm in length was discovered.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.The returned sample will be returned to the manufacturing site for further evaluation.The reported complaint of the medical agent not injecting through the catheter was confirmed during functional inspection of the returned sample.The returned epidural catheter was found to be completely occluded.The extrusion was cut at approximately 46cm from the proximal end to determine what was causing the blockage.A clear crystalized looking material less than 1cm in length was discovered.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.Based on the discovered blockage, the returned sample will be returned to the manufacturing site for further evaluation.

Event Description

The user was unable to inject the medical agent through the catheter after insertion.Therefore, the catheter was replaced with a new one.Additional information: flushing test was performed on the catheter before insertion and after removal from the patient, but no problem was found then.

Event Description

The user was unable to inject the medical agent through the catheter after insertion.Therefore, the catheter was replaced with a new one.Additional information: flushing test was performed on the catheter before insertion and after removal from the patient, but no problem was found then.

Manufacturer Narrative

(b)(4).Device history record review was performed on the epidural catheter with no relevant findings.The customer reported the medical agent could not be injected through the catheter.The customer returned one flat filter nrfit, one snaplock assembly nrfit, and an epidural catheter.The returned snaplock assembly and catheter were received connected together.The returned components were visually examined with and without magnification.Visual examination of the returned filter and snaplock assembly revealed both components appear 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.No other defects or anomalies were observed.A functional flow test was performed on the returned sample per amrq-000017 section 7.8; rev.10.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 (b)(4) 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 46.6cm (ruler: 10171599) 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 43.8cm from the distal end of the returned catheter until an occlusion was found.Microscopic examination where the catheter was blocked indicated biological material is present between the catheter's inner coils.The extrusion of the returned catheter was cut at approximately 46cm from the proximal end to determined what was causing the occlusion.A clear crystalized looking material less than 1cm in length was discovered.The returned sample was returned to the manufacturing site for further evaluation.The manufacturing site's evaluation concluded the catheter was manufactured per manufacturing procedures as no issues were found.The manufacturing could not determine how the small material was present inside the returned catheter.However, the manufacturing site indicated based on the complaint description that the customer was able "flush" the catheter prior to and after removal from the patient, this issue was most likely not manufacturing related.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.The reported complaint of the medical agent not injecting through the catheter was confirmed during functional inspection of the returned sample.The returned epidural catheter was found to be completely occluded.The extrusion was cut at approximately 46cm from the proximal end to determine what was causing the blockage.A clear crystalized looking material less than 1cm in length was discovered.The sample was returned to the manufacturing site for further evaluation.The manufacturing site concluded; it could not be determined how the small material was present inside the returned catheter.However, based on the complaint description that the customer was able "flush" the catheter prior to and after removal from the patient, this issue was most likely not manufacturing related.A device history record review was performed on the epidural catheter with no evidence to suggest a manufacturing related cause.Therefore, based upon the information provided and the condition of the sample received, the potential cause of this complaint could not be determined.

• Brand Name: EPIDURAL CATHETERIZATION KIT NRFIT
• 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: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 13535359
• MDR Text Key: 288366685
• Report Number: 3006425876-2022-00199
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2023
• Device Catalogue Number: TU-05500-NRO
• Device Lot Number: 71F21J0887
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/14/2021
• 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